Chiropractic Services

Number: 0107

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

Policy

Scope of Policy

This Clinical Policy Bulletin addresses chiropractic services.

Medical Necessity
1. Aetna considers chiropractic services medically necessary when all of the following criteria are met:
  1. The member has a neuromusculoskeletal disorder; and
  2. The medical necessity for treatment is clearly documented; and
  3. Improvement is documented within the initial 2 weeks of chiropractic care.
  If no improvement is documented within the initial 2 weeks, additional chiropractic treatment is considered not medically necessary unless the chiropractic treatment is modified.
  
  If no improvement is documented within 30 days despite modification of chiropractic treatment, continued chiropractic treatment is considered not medically necessary.
  
  Once the maximum therapeutic benefit has been achieved, continuing chiropractic care is considered not medically necessary.
2. Home-based chiropractic service is considered medically necessary in selected cases based upon the member's needs (i.e., the member must be homebound). This may be considered medically necessary in the transition of the member from hospital to home, and may be an extension of case management services.
3. Chiropractic manipulation in asymptomatic persons or in persons without an identifiable clinical condition is considered not medically necessary.
4. Chiropractic care in persons, whose condition is neither regressing nor improving, is considered not medically necessary.
  Chiropractic manipulation has no proven value for treatment of idiopathic scoliosis or for treatment of scoliosis beyond early adolescence, unless the member is exhibiting pain or spasm, or some other medically necessary indications for chiropractic manipulation are present.
Experimental and Investigational
1. Aetna considers the following procedures experimental and investigational:
  1. Manipulation when it is rendered for non-neuromusculoskeletal conditions (see examples below, not an all-inclusive list):
    1. Attention-deficit hyperactivity disorder
    2. Asthma
    3. Autism spectrum disorder
    4. Depression
    5. Dizziness / vertigo
    6. Dysmenorrhea
    7. Epilepsy
    8. Female infertility
    9. Gastro-intestinal disorders
    10. Improvement of brain function
    11. Menopause-associated vasomotor symptoms
    12. Prevention of falls
    13. Treatment of post-concussion syndrome;
  2. Manipulation of infants for non-neuromusculoskeletal indications (see examples below, not an all-inclusive list):
    1. Infants with gastro-intestinal disorders including constipation
    2. Excessive intestinal gas
    3. Gastroesophageal reflux disease;
  3. Chiropractic procedures:
    1. Active Release Technique (see CPB 0388 - Complementary and Alternative Medicine)
    2. Active Therapeutic Movement (ATM2)
    3. Advanced Biostructural Correction (ABC) Chiropractic Technique
    4. Applied Spinal Biomechanical Engineering
    5. Atlas Orthogonal Technique
    6. Bioenergetic Synchronization Technique
    7. Biogeometric Integration
    8. Blair Technique
    9. Bowen Technique
    10. Chiropractic Biophysics Technique / Chiropractic BioPhysics Methods
    11. Coccygeal Meningeal Stress Fixation Technique
    12. ConnecTX (an instrument-assisted connective tissue therapy program)
    13. Cox decompression manipulation/technique
    14. Cranial Manipulation
    15. Directional Non-Force Technique
    16. FAKTR (Functional and Kinetic Treatment with Rehab) Approach
    17. Gonzalez Rehabilitation Technique
    18. Inertial traction (inertial extensilizer decompression table
    19. IntraDiscNutrosis program
    20. Koren Specific Technique
    21. Manipulation for infant colic
    22. Manipulation for internal (non-neuromusculoskeletal) disorders (Applied Kinesiology)
    23. Manipulation Under Anesthesia (see CPB 0204 - Manipulation Under General Anesthesia)
    24. Moire Contourographic Analysis
    25. Network Technique
    26. Neural Organizational Technique
    27. Neuro Emotional Technique
    28. NUCCA (National Upper Cervical Chiropractic Association) procedure
    29. Origin insertion release technique
    30. Positional release therapy
    31. Sacro-Occipital Technique
    32. Spinal Adjusting Devices (Activator, ProAdjuster, PulStarFRAS, Ultralign adjusting device)
    33. Therapeutic (Wobble) Chair
    34. Upledger Technique and Cranio-Sacral Therapy
    35. Webster Technique (for breech babies)
    36. Whitcomb Technique (see CPB 0388 - Complementary and Alternative Medicine);
  4. Diagnostic procedures:
    1. Computerized radiographic mensuration analysis for assessing spinal mal-alignment
    2. Dynamic spinal visualization (including digital motion x-ray and videofluoroscopy, also known as cineradiography)
    3. Neurocalometer/Nervoscope (see CPB 0029 - Thermography)
    4. Para-spinal electromyography (EMG) / Surface scanning EMG (see CPB 0112 - Surface Scanning and Macro Electromyography)
    5. Spinoscopy (see CPB 0112 - Surface Scanning and Macro Electromyography)
    6. Thermography (see CPB 0029 - Thermography).
Policy Limitations and Exclusions

Note: Some plans have limitations or exclusions applicable to chiropractic care. Please check benefit plan descriptions for details.
Related Policies

Table:
CPT Codes / HCPCS Codes / ICD-10 Codes
Code	Code Description
CPT codes covered if selection criteria are met:
98940	Chiropractic manipulative treatment (CMT); spinal, one to two regions
98941	spinal, three to four regions
98942	spinal, five regions
98943	extraspinal, one or more regions
CPT codes not covered for indications listed in the CPB:
ConnecTX, inertial traction, positional release therapy, IntraDiscNutrosis program, Origin insertion release technique, Ultralign adjusting device - no specific code:
22505	Manipulation of spine requiring anesthesia, any region
97530	Therapeutic activities, direct (one-on-one) patient contact (use of dynamic activities to improve functional performance), each 15 minutes [not covered for FAKTR]
Other CPT codes related to the CPB:
20552	Injection(s); single or multiple trigger point(s), one or two muscle(s)
20553	single or multiple trigger point(s), three or more muscle(s)
20560	Needle insertion(s) without injection(s); 1 or 2 muscle(s)
20561	3 or more muscles
95836 - 95857	Muscle and range of motion testing
95860 - 95887	Electromyography and nerve conduction tests
95907 - 95913	Nerve conduction studies
95937	Neuromuscular junction testing (repetitive stimulation, paired stimuli), each nerve, any 1 method
96000 - 96004	Motion analysis
97010 - 97799	Physical medicine and rehabilitation
HCPCS codes covered if selection criteria are met:
Home-based chiropractic service - no specific code
Other HCPCS codes related to the CPB:
G0151	Services performed by a qualified physical therapist in the home health or hospice setting, each 15 minutes
S3900	Surface electromyography (EMG)
S9131	Physical therapy; in the home, per diem
ICD-10 codes covered if selection criteria are met (0-3 years of age):
G24.3	Spasmodic torticollis
G54.0 - G55	Nerve root and plexus disorders
G71.0 - G72.9	Primary disorders of muscles and other myopthies
G80.0 - G80.9	Cerebral palsy
M05.00 - M08.99	Rheumatoid arthritis and other inflammatory polyarthropathies
M40.00 - M40.51, M42.00 -M54.9	Deforming dorsopathies, spondylitis and other dorsopathies [excluding scoliosis]
M91.10 - M94.9	Chondropathies
Q65.00 - Q68.8	Congenital musculoskeletal deformities
Q72.70 - Q72.73, Q74.1 - Q74.2	Congenital malformations of lower limb, including pelvic girdle
Q74.0, Q74.9, Q87.89	Congenital malformations of upper limb, including shoulder girdle
Q76.0 - Q76.49	Congenital malformations of spine
Q77.0 -Q77.1 Q77.4 - Q77.5 Q77.7 - Q77.9 Q78.9	Osteochrondrodysplasia
S03.4xx+	Sprain of jaw
S13.0xx+ - S13.9xx+, S23.0xx+ - S23.9xx+, S33.0xx+ - S33.9xx+, S43.001+ - S43.92X+, S53.001+ - S53.499, S63.001+ - S63.92X+, S73.001+ - S73.199+, S83.001 - S83.92X+, S93.01X+ - S93.699+	Dislocation and sprains of joint and ligaments
S14.2xx+ - S14.9xx+, S24.2xx+ - S24.9XX+, S34.21x+ - S34.9XX+	Injury to nerve roots, spinal plexus and other nerves
S16.1xx+	Strain of muscle, fascia and tendon at neck level
S23.41x+ - S23.429+, S33.4xx+ S33.8xx+ - S33.9xx+	Sprain of other ribs, sternum, and pelvis
S39.002+, S39.012+, S39.092+	Injury or strain of muscle, fascia and tendon of lower back
S44.00x+ - S44.92x+	Injury of nerves at shoulder and upper arm level
S46.011+ - S46.019+, S46.111+ - S46.119+, S46.211+ - S46.219+, S46.311+ - S46.319+, S46.811+ - S46.819+, S46.911+ - S46.919+	Injury of muscle, fascia and tendon at shoulder and upper arm level
S74.00x+ - S74.92x+	Injury of nerves at hip and thigh level
S76.011+ - S76.019+, S76.111+ - S76.119+, S76.211+ - S76.219+, S76.311+ - S76.319+, S76.811+ - S76.819+, S76.911+ - S76.919+	Injury and strain of muscle, fascia and tendon at hip and thigh level
S84.00x+ - S84.92x+	Injury of nerves at lower leg level
S86.001+ - S86.019+, S86.111+ - S86.119+, S86.211+ - S86.219+, S86.311+ - S86.319+, S86.811+ - S86.819+, S86.911+ - S86.919+	Injury of muscle, fascia and tendon at lower leg level
S94.00x+ - S94.92x+	Injury of nerves at ankle and foot level
S96.001+ - S96.019+, S96.111+ - S96.119+, S96.211+ - S96.219+, S96.811+ - S96.819+, S96.911+ - S96.919+	Injury of muscle, fascia and tendon at ankle and foot level
ICD-10 codes covered if selection criteria are met for adults and children (4 years of age and older):
G24.3	Spasmodic torticollis
G43.001 - G43.919	Migraine
G44.001 - G44.89	Tension and other headaches
G54.0 - G55	Nerve root and plexus disorders
G56.00 - G56.93	Mononeuritis of upper limb
G57.00 - G59	Mononeuritis of lower limb
G71.00 - G72.9	Muscular dystrophies and other myopathies
G80.0 - G80.9	Cerebral palsy
M05.00 - M08.99	Rheumatoid arthritis and other inflammatory polyarthropathies
M12.00 - M13.89	Other and unspecified arthropathies
M15.0 - M19.93	Osteoarthritis and allied disorders
M20.001 - M25.9	Other joint disorders
M26.601 - M26.69	Temporomandibular joint disorders
M35.3, M75.00 - M79.9	Rheumatism, shoulder lesions and enthesopathies [excludes back]
M40.00 - M40.51, M42.00 - M54.9	Deforming dorsopathies, spondylitis and other dorsopathies [excluding scoliosis]
M85.30 - M85.39	Osteitis condensans
M89.00 - M89.09	Algoneurodystrophy
M91.10 - M94.9	Osteochondropathies
M95.3	Acquired deformity of neck
M95.5	Acquired deformity of pelvis
M95.8	Other specified acquired deformities of musculoskeletal system
M95.9	Acquired deformities of musculoskeletal system, unspecified
M99.00 - M99.09	Segmental and somatic dysfunction [allowed by CMS]
M99.10 - M99.19	Subluxation complex (vertebral)
M99.83 - M99.84	Other acquired deformity of back or spine
Numerous options	Other, multiple, and ill-defined dislocations [including vertebra]
Q65.00 - Q68.8	Congenital musculoskeletal deformities
Q74.1 - Q74.2	Congenital malformations of lower limb, including pelvic girdle
Q74.0, Q74.9, Q87.89	Congenital malformations of upper limb, including shoulder girdle
Q76.0 - Q76.49	Congenital malformations of spine
Q77.0 -Q77.1 Q77.4 - Q77.5 Q77.7 - Q77.9 Q78.9	Osteochrondrodysplasia
R51	Headache
S03.40x+ - S03.42x+	Sprain of jaw
S13.0xx+ - S13.9xx+, S23.0xx+ - S23.9xx+, S33.0xx+ - S33.9xx+, S43.001+ - S43.92X+, S53.001+ - S53.499, S63.001+ - S63.92X+, S73.001+ - S73.199+, S83.001 - S83.92X+, S93.01X+ - S93.699+	Dislocation and sprains of joints and ligaments
S14.2xx+ - S14.9xx+, S24.2xx+ - S24.9XX+ S34.21x+ - S34.9xx+	Injuries to nerve root(s), spinal plexus(es) and other nerves
S16.1xx+	Strain of muscle, fascia and tendon at neck level
S23.41x+ - S23.429+, S33.4xx+ S33.8xx+ - S33.9xx+	Sprain of other ribs, sternum, and pelvis
S39.002+, S39.012+, S39.092+	Injury or strain of muscle, fascia and tendon of lower back
S44.00x+ - S44.92x+	Injury of nerves at shoulder and upper arm level
S46.011+ - S46.019+, S46.111+ - S46.119+, S46.211+ - S46.219+, S46.311+ - S46.319+, S46.811+ - S46.819+, S46.911+ - S46.919+	Injury of muscle, fascia and tendon at shoulder and upper arm level
S74.00x+ - S74.92x+	Injury of nerves at hip and thigh level
S76.011+ - S76.019+, S76.111+ - S76.119+, S76.211+ - S76.219+, S76.311+ - S76.319+, S76.811+ - S76.819+, S76.911+ - S76.919+	Injury and strain of muscle, fascia and tendon at hip and thigh level
S84.00x+ - S84.92x+	Injury of nerves at lower leg level
S86.001+ - S86.019+, S86.111+ - S86.119+, S86.211+ - S86.219+, S86.311+ - S86.319+, S86.811+ - S86.819+, S86.911+ - S86.919+	Injury of muscle, fascia and tendon at lower leg level
S94.011+ - S94.019+, S94.111+ - S94.119+, S94.211+ - S94.219+, S94.311+ - S94.319+, S94.811+ - S94.819+, S94.911+ - S94.919+	Injury of nerves at ankle and foot level
S96.001+ - S96.019+, S96.111+ - S96.119+, S96.211+ - S96.219+, S96.811+ - S96.819+, S96.911+ - S96.919+	Injury of muscle, fascia and tendon at ankle and foot level
ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):
F07.81	Postconcussional syndrome
F32.0 - F32.9	Major depressive disorder, single episode
F33.0 - F33.9	Major depressive disorder, recurrent
F84.0 - F84.9	Pervasive developmental disorder
F90.0 - F90.9	Attention deficit hyperactivity disorder
G40.001 - G40.919	Epilepsy and recurrent seizures
H81.01 - H81.49	Vertigo
J45.20 - J45.998	Asthma
K00.0 - K95.89	Diseases of the digestive system
M41.00 - M41.9	Scoliosis [and kyphoscoliosis], idiopathic; resolving infantile idiopathic scoliosis; and progressive infantile idiopathic scoliosis
N94.4 - N94.6	Dysmenorrhea
N95.1	Menopausal and female climacteric states [not covered for menopause-associated vasomotor symptoms]
N97.0 - N97.9	Female infertility
O32.1xx0 - O32.1xx9	Maternal care for breech presentation
R10.83	Colic
R42	Dizziness and giddiness
R56.1	Post traumatic seizures
R56.9	Unspecified convulsions [seizure disorder NOS]
Z91.81	History of falling

Background

Chiropractic is a branch of the healing arts that is concerned with human health and prevention of disease, and the relationship between the neuroskeletal and musculoskeletal structures and functions of the body. The primary focus of chiropractic is the relationship of the spinal column and the nervous system, as it relates to the restoration and maintenance of health. A practitioner of chiropractic is referred to as Doctor of Chiropractic (D.C.), Chiropractic Physician or Chiropractor.

The primary focus of the profession is the vertebral column; however, all other peripheral articular structures and adjacent tissues may be treated, depending on state chiropractic scope of practice laws.

Neuromusculoskeletal conditions commonly treated by chiropractic physicians include:

Contractures
Degenerative conditions of the joints
Fibrositis
Headaches (including tension headaches, migraines, and vertebrogenic-type headaches)
Myalgia
Myofibrositis
Neuralgias
Non-infectious inflammatory disorders of the joints, muscles, and ligaments of the spine and extremities
Osteoarthritis – Intervertebral disc disorders of the spine such as disc protrusion, bulging, degeneration, and displacement
Peripheral joint trauma
Radiculopathies
Repetitive motion injuries
Spinal facet syndromes
Spondylolisthesis
Spondylosis
Sprains and strains.

The chiropractor may treat multiple neuromusculoskeletal conditions during a single visit.

Chiropractors use broadly accepted diagnostic procedures to assess diseases and adverse health conditions.

The primary mode of chiropractic treatment is manipulation or adjustment. Chiropractic manipulation is the application of a controlled force to re-establish normal articular function. The objective of manipulation is to restore the normal mobility and range of motion within the joint.

The chiropractor affects the body's physiology and promotes healing by locating and correcting mechanical disorders of joints or joint subluxations. In chiropractic, the term "subluxation" is used interchangeably with the term "spinal subluxation complex" or "vertebral subluxation complex". A subluxation may also be called a joint dysfunction, joint fixation, functional joint lesion, somatic dysfunction, or biomechanical dysfunction. A subluxation has been defined as a fixation, lack of motion, or aberrant motion of an articular joint, resulting in physiological changes within the joint that may cause inflammation of the joint and its capsule, which may result in pain, swelling, muscle spasm, nerve irritation, damage to joint cartilage, and loss of normal range of motion. Nerve irritation may cause pain and spasm to radiate. Vascular, sensory, and motor changes may accompany a spinal subluxation complex.

Some non-neuromusculoskeletal conditions may be managed by chiropractors when practicing within the scope of their licenses. In assessing the need for chiropractic treatment, both neuromusculoskeletal conditions and any related coexisting non-neuromusculoskeletal disorders should be considered.

Chiropractors treat disease without the use of medications or surgery. When medication or surgery is indicated, the chiropractor should refer the patient to an allopathic or osteopathic physician, as appropriate. Patients may receive medical treatment from an allopathic or osteopathic physician simultaneously or in conjunction with a chiropractic physician.

Chiropractors may diagnose disease and prescribe office-based treatments and home exercises. Chiropractors do not commonly make house calls.

In addition to manipulation, chiropractors may employ adjunctive nutritional, hygienic, and environmental modalities, physiotherapeutic modalities, rehabilitation, and therapeutic massage for the treatment of subluxation and related conditions. The use of adjunctive modalities must be appropriate for the diagnosis and must augment or enhance the manipulative treatment. The type of therapy used should be consistent with the status of the patient's condition (e.g., acute, subacute, rehabilitative or chronic).

Examples of adjunctive physiotherapeutic measures that have been used in chiropractic include:

Acute phase: thermal (cold) therapy, electrotherapy, trigger point therapy;
Rehabilitative phase: exercise; and
Subacute phase: thermal (heat), electrotherapy, ultrasound.

Massage therapy and traction procedures are not considered to be manipulation.

Literature indicates that chiropractic treatment during pregnancy may be appropriate. Chiropractic therapy is often effective in reducing back pain and allowing the pregnant patient to function and perform her activities of daily living.

Physical Therapy Modalities

Although chiropractors often use physical modalities with spinal manipulation, there is a lack of evidence that modalities yield additional benefits over spinal manipulation alone. The UCLA Back Pain Study examined the net effect of physical modalities on low back pain outcomes among chiropractic patients in a managed-care setting (Hurwitz et al, 2002; Hurwitz et al, 2006). Half of the 681 patients participating in this clinical trial of low back pain treatment strategies were randomized to chiropractic care with physical modalities (n = 172) or without physical modalities (n = 169). The other half of the study subjects were assigned to medical care with or without physical therapy modalities. Subjects were followed for 6 months with assessments at 2, 4, and 6 weeks and at 6 months. The primary outcome variables were average and most severe low back pain intensity in the past week, assessed with numerical rating scales (0 to 10), and low back-related disability, assessed with the 24-item Roland-Morris Disability Questionnaire. Almost 60 % of the subjects had baseline low back pain episodes of more than 3 months' duration. The 6-month follow-up was 96 %. The investigators reported, comparing groups assigned to chiropractic alone to chiropractic plus physical therapy modalities, the adjusted mean differences between groups in improvements in average and most severe pain and disability were clinically insignificant at all follow-up assessments (Hurwitz et al, 2002). The investigators reported that clinically relevant improvements in average pain and disability were more likely in the modalities group at 2 and 6 weeks, but this apparent advantage disappeared at 6 months. Perceived treatment effectiveness was greater in the modalities group. The investigators concluded that physical modalities used by chiropractors in this study did not appear to be effective in the treatment of patients with low back pain, although the investigators noted that a small short-term benefit for some patients cannot be ruled out. In a subsequent report on the 18-month outcomes of the UCLA Back Pain Study, 89.6 % of the original cohort were followed through 18 months (Hurwitz et al, 2006). Among study subjects assigned to chiropractic care, assignment to physical therapy modalities in addition to chiropractic was not associated with improvement or remission (adjusted RR = 0.98; 95 % confidence interval [CI]: 0.62 to 1.55) compared to chiropractic care alone. The investigators concluded that physical modalities appear to have no benefit in chiropractic care.

In another publication, Haas et al (2004) reported on a randomized controlled pilot study conducted in the faculty practice of a chiropractic college outpatient clinic examining the effects of the number of chiropractic treatment visits for manipulation with and without physical modalities on chronic low back pain and disability. The study involved 72 patients with chronic, non-specific low back pain of mechanical origin. All patients received high-velocity low-amplitude spinal manipulation. Half received one or two of the following physical therapy modalities at each visit: soft tissue therapy, hot packs, electrotherapy or ultrasound. The investigators reported that, at 4 weeks, there was no effect of treatment regimen (chiropractic or chiropractic plus physical therapy modalities) on pain or functional disability at 4 weeks or 12 weeks follow-up.

In another randomized controlled clinical study, joint manipulation plus myofascial therapy was found to be no more effective than joint manipulation alone for persons with subacute low back pain. Hsieh et al (2002) reported on the results of a randomized, assessor-blinded clinical trial to investigate the relative effectiveness of 3 manual treatments and back school for patients with subacute low back pain. Two hundred patients with subacute low back pain were randomly assigned to one of four treatments for 3 weeks: back school, joint manipulation, myofascial therapy, and combined joint manipulation and myofascial therapy. The investigators reported that all 4 groups showed significant improvement in pain and activity scores after 3 weeks of care, but did not show further significant improvement at the 6-month follow-up assessment. No statistically significant differences were found among treatment groups at either at the 3-week or 6-month reassessments. The investigators concluded that, for subacute low back pain, combined joint manipulation and myofascial therapy was no more effective than joint manipulation or myofascial therapy alone.

Experimental and Investigational Interventions

Some diagnostic and therapeutic procedures are not considered medically necessary or essential to the treatment of an illness or injury and are not broadly accepted by the chiropractic profession.

Manipulation is deemed experimental and investigational when it is rendered for non-neuromusculoskeletal conditions, because the effectiveness of chiropractic manipulation for this indication has not been proven by adequate scientific studies, published in peer-reviewed scientific journals. An example is the use of manipulation in lieu of antibiotics for treatment of suppurative otitis media. Manipulative procedures are not proven to be an effective substitute for childhood immunizations or for the treatment of infectious diseases, and are not covered for these indications.

Chiropractic/manipulative management of scoliosis has not been shown to substantially alter the idiopathic scoliotic curve or progression of the curve in late adolescence or adulthood. Therefore, chiropractic manipulation is considered unproven and is not covered for treatment of idiopathic scoliosis or for treatment of scoliosis beyond early adolescence, unless the patient is exhibiting pain or spasm or if some other medically necessary indication for chiropractic manipulation is present.

Scoliotic deviations may be a result of functional adaptations to lumbo-pelvic lower extremity dysfunction for which chiropractic care is appropriate. Manipulative procedures, in conjunction with electrical muscle stimulation and exercise, can significantly reduce the associated muscle spasm and resultant pain of scoliosis during the acute exacerbations and/or injury, and improve spinal mobility prior to an active exercise regimen. Chiropractic/manipulative management of scoliosis, however, has not been shown to substantially alter the idiopathic scoliotic curve or progression of the curve in late adolescence or adulthood. In a systematic literature review of non-surgical treatment in adult scoliosis, Everett and Patel (2007) stated that there is only very weak evidence for the use of chiropractic manipulation in adult deformity.

The use of chiropractic to correct abnormal spinal curvature in asymptomatic persons is considered experimental and investigational. Chiropractic Biophysics Technique (CPB), also known as Clinical Biomechanics of Posture, is a variation of straight (subluxation-based) chiropractic whose overall goal is to restore posture. Advocates of CBP are reported to ascribe to the controversial position that decreased neck curvature is pathological and requires correction whether or not the patient has symptoms.

The CBP method is based on the idea that postural analysis is valid for diagnosing ligament contractures, muscle weakness, and proprioceptive deficits. The assumed deficits supposedly reduce blood flow, which decreases oxygen delivery and causes various diseases. To qualify for treatment, patients undergo a postural examination and are screened for contraindications to manipulation and cervical extension traction. Therapy begins with relief care consisting of 1 to 12 sessions of spinal adjustments, cold or hot packs, trigger point therapy for muscle spasms, and/or massage with a motorized table. When relief care ends, CBP practitioners switch patients to rehabilitative care, which consists of weekly mirror image adjustments, neck and low back extension traction, as well as mirror image exercises intended to modify spinal curvature over a longer period of time. Initial rehabilitative plans often last 6 to 12 months, after which patients are switched to monthly visits for life.

There is insufficient scientific evidence to support the use of CBP. The published peer reviewed literature focuses primarily on explaining the theoretical basis for the Chiropractic Biophysics Technique. Harrison et al (1996) discussed the theory underlying the Chiropractic Biophysics Technique, explaining how certain linear algebra concepts provide the theoretical basis for making postural corrections. The authors explained how Chiropractic Biophysics Technique uses these concepts in examination procedures, manual spinal manipulation, instrument assisted spinal manipulation, postural exercises, extension traction and clinical outcome measures. Jackson et al (1993) reported on the intra- and inter-rater reliability of the geometric line drawings used in CBP on lateral cervical radiographs. The investigators concluded that the reliabilities for intra- and inter-examiner were accurate enough to provide measurements for future clinical studies.

There is a paucity of published peer reviewed literature evaluating the effectiveness of the Chiropractic Biophysics Technique in improving clinical outcomes (e.g., reductions in pain and disability, improvements in function). Colloca and Polkinghorn (2003) described the use of CBP protocols in conjunction with other chiropractic techniques in 2 persons with Ehlers-Danlos syndrome. In a 10-year follow-up study of neck x-ray findings in asymptomatic patients, Gore (2001) found no relationship between the loss of neck curvature and the development of pain or degenerative changes. Haas and colleagues (1999) noted that changes in spinal structure do not necessarily cause symptoms. They stated that CBP advocates have failed to

establish the biological plausibility of what they consider an ideal spine,
show that their diagnostic tests enable better patient management,
demonstrate meaningful outcomes such as decreased pain or disability, and
validate the routine use of spinal x-rays to measure spinal displacement.

Active release technique (ART) is a patented soft tissue system that treats problems with muscles, tendons, ligaments, fascia and nerves (e.g., headaches, back pain, carpal tunnel syndrome, shin splints, shoulder pain, sciatica, plantar fasciitis, knee problems, and tennis elbow). These conditions have one important commonality – they often result from injury to over-used muscles. Each ART session is a combination of examination and treatment. The ART provider uses his/her hands to evaluate the texture, tightness and movement of muscles, fascia, tendons, ligaments and nerves. Abnormal tissues are treated by combining precisely directed tension with very specific patient movements. These treatment protocols – over 500 specific moves – are unique to ART. They supposedly allow providers to identify and correct the specific problems that are affecting each individual patient. Active release technique is similar to some massage techniques, albeit more aggressive.

While ART may be utilized by some chiropractors, it is different from conventional chiropractic manipulation. Furthermore, Drover et al (2004) reported that ART protocols did not reduce inhibition or increase strength in the quadriceps muscles of athletes with anterior knee pain. Further study is required.

There is inadequate evidence of the effectiveness of spinal manipulation in treatment of dysmenorrhea. In a Cochrane review, Proctor et al (2006) concluded that there is no evidence to suggest that spinal manipulation is effective in the treatment of primary and secondary dysmenorrhea.

There is inadequate evidence of the effectiveness of chiropractic for treatment of epilepsy. In a review on the use of complementary and alternative medicine (CAM) including manipulative-based medicine such as chiropractic in the treatment of epilepsy, Ricotti and Delanty (2006) noted that in the available literature, there is a sense of the merit of these therapies in epilepsy, but there is a paucity of research in these areas. The authors stated that, in a science of double-blind, randomized controlled trials, appropriate designs and outcome measurements need to be tailored to CAM. More effort needs to be put into future trials, with the assistance of qualified CAM professionals to ensure conformation to their therapeutic principles.

The ProAdjuster is a hand-held device most commonly used by chiropractors for the diagnosis and treatment of back pain. The technology associated with this device entails the use of a piezoelectric sensing head/probe that is pressed onto the spine sending ultrasound to the vertebral column for measurements of movement of each vertebra or the lack of it. A series of signal waves, each representing an individual vertebra, appears on a computer screen beside digital bar charts, where longer, red bars indicate a mis-alignment in the lower spine. When the ProAdjuster identifies a problem, it then delivers a series of rapid and measured percussion taps that works like a traditional chiropractic adjustment. The sensing system will automatically stop the adjustment when normal motion is detected.

There is insufficient scientific evidence regarding the clinical value of the ProAdjuster for the management of patients with back pain or any other conditions. Available published literature centers on the piezoelectric sensor technology. According to Zhang and Fu (2004), piezoelectric quartz crystal biosensor is a new sensor with the comprehensive utilization of the high sensitivity to mass and the surface characteristics of quartz crystal (e.g., conductance, density, dielectric constant, viscosity), as well as the high specificity of biologic identification molecules. The authors state that piezoelectric quartz crystal biosensors have been used in various settings such as environmental monitoring (e.g., detection of organophosphate levels in river water), foods sanitary control (e.g., detection of sulfamethoxazole residue or Salmonella in milk), as well as medical laboratory diagnosis (e.g., DNA biosensor, biosensor for estrogenic substances, and micro-array immunosensor for quantitative detection of serum or urine human chorionic gonadotropin).

Beck and colleagues (2006) compared a piezoelectric contact sensor with an accelerometer for measuring the mechanomyographic (MMG) signal from the biceps brachii during sub-maximal to maximal isokinetic and isometric forearm flexion muscle actions. These researchers found that there were no significant relationships for normalized MMG mean power frequency (MPF, percent maximum) versus isokinetic and isometric torque for the contact sensor, but the accelerometer demonstrated a quadratic or linear relationship for the isokinetic and isometric muscle actions, respectively. There were also a number of significant mean differences between the contact sensor and accelerometer for normalized MMG amplitude or MPF values. The findings of this study indicated that in some cases involving dynamic and isometric muscle actions, the contact sensor and accelerometer resulted in different torque-related responses that may affect the interpretation of the motor control strategies involved.

A number of other spinal adjusting instruments have been developed that share similarities to the ProAdjuster, including the PulStarFRAS. Similar to the ProAdjuster, the PulStarFRAS (Function Recording and Analysis System) can be used for diagnostic as well as therapeutic purposes. The PulStarFRAS is designed to generate an objective and repeatable analysis of the mobility (compliance) of the spinal structure. The resulting computerized differential compliance (CDC) scans are used as an aid in the identification of spinal joint dysfunction. The PulStarFRAS provides a low-force multiple impulse therapy to resolve joint fixation. There is a lack of adequate evidence regarding its clinical value of the PulStarFRAS.

The Activator is a spinal adjusting instrument that is similar to the ProAdjuster in that it provides low force. The Activator Methods Chiropractic Technique system of analysis isolates and locates euronro-articular dysfunctions or subluxations by observing changes in relative leg length while the patient lies prone on a treatment table. The Activator Adjusting Instrument is applied based on indications from the analysis as to somatic location and force vector. The Activator produces a maximum of 0.3 Joules of kinetic energy, which is intended to be sufficient to induce relative movement of vertebrae and their associated joints, but below the forces associated with tissue injury.

There is insufficient evidence to validate the clinical validity of the Activator Methods Chiropractic Technique methods of leg length analysis. In addition, there is insufficient evidence that use of the Activator results in benefits equivalent to the more studied methods of manual chiropractic manipulation.

A study by Wood et al (2001) is a controlled clinical outcome study comparing the Activator technique to manual manipulation. In a pilot study (n = 30), Wood et al (2001) found that both instrumental manipulation by means of the Activator II Adjusting Instrument and manual manipulation have beneficial effects associated with reducing pain and disability and improving cervical range of motion in patients with neck pain. In this study, subjects were randomly assigned to 2 groups: one group was assigned to manipulation with the Activator, the other to manual chiropractic manipulation using a standard technique. The Activator Methods Chiropractic Technique of leg length analysis was used to determine treatment locations in both the instrument group and the manual group. All treatments, both manual and instrumental, were applied by a single chiropractor. Subjects were treated until they were asymptomatic or received a maximum of 8 treatments, and were followed for 1 month after completion of therapy. The investigators reported that no significant differences were observed between the instrumental manipulation group and the manual manipulation group with respect to subjective outcomes (pain and disability) and objective outcomes (range of motion) (p > 0.025). The study has a number of important limitations, including the small sample size, so that the study may be under-powered to detect clinically significant differences in outcomes among groups. In addition, the small size of the study and the fact that all treatments were provided by a single chiropractor raise questions about the generalizability of the findings. The investigator who assessed the clinical outcomes was not blinded to group assignment, raising the possibility of examiner bias. The short duration of follow-up in this study does not allow one to compare the durability of results of these treatments. The statistical analysis used in this study was inappropriate to answer the key question about the effectiveness of the Activator compared to manual therapy in that the study used a superiority design rather than a more stringent non-inferiority design (i.e., the null hypothesis of this study was that there were no significant differences between the groups in clinical improvement). The investigators stated that future studies could benefit from including an untreated group and a sham treatment group to determine the true clinical benefits of these manipulative procedures. The investigators concluded that a randomized controlled clinical trial in a similar patient base with a larger sample size is necessary to verify the clinical relevance of these findings.

An unpublished study (Pfefer et al, 2007) compared the outcomes in terms of pain and function of acute low back pain patients treated with either Activator Methods Chiropractic Technique or a standard method of chiropractic manipulation (diversified chiropractic spinal manipulation). A total of 47 patients with acute or subacute low back pain were randomly assigned to the Activator Technique or manual chiropractic manipulation. Each treatment group had a single chiropractic practitioner. The Activator doctor used the standard Activator leg length discrepancy protocols, whereas the manual therapy doctor used a combination of motion and static palpation to determine the areas to be treated. Subjects were treated with duration and frequency at the clinical discretion of each group's treating chiropractor, for up to 6 weeks. Subjects were assessed at study initiation, at weekly intervals for the first 3 weeks of therapy, and at week 6. The investigators reported that the null hypothesis of non-equivalence was rejected for measure of disability (the Modified Oswestry disability questionnaire score), but not for pain (Visual Analog Scores (VAS) for pain). This study avoided some of the limitations of the study by Woods et al, in that it used an equivalence design for statistical analysis rather than a superiority design; tolerance was set at 20 %, so that the 2 treatments could differ from each other by up to 20 % and still be considered equivalent. Outcomes were assessed in a blinded manner by student research assistants. The investigators noted that a clear weakness of this study is confounding of the provider with the technique, and that future studies could address this issue by assigning several providers of equal competence to deliver the technique. Other limitations of this study are the small sample sizes and limited duration of follow-up.

Kawchuk et al (2006) reported on a study comparing variability in the magnitude and duration of force produced by manual and instrument-based manipulation. In this study, 4 therapists (2 novices and 2 experts certified in the use of Activator instruments by the manufacturer) used 4 different mechanical instruments to apply force to a load cell fixed to a rigid surface. These 4 instruments included 2 spring-based instruments (the Activator IV and the Activator Signature), a compressed gas instrument (the Air Activator), and an electromechanical instrument (the Impulse from Neuromechanical Innovations, Phoenix, AZ). A different group of 2 experts licensed in chiropractic and 2 unlicensed novices used traditional manual techniques to apply force to a sensor mat. The investigators reported that manual applications of force were generally greater in magnitude and duration than those delivered by instrument. The mean force of all manual applications was 264 Newtons and the mean force duration was 145 milliseconds, whereas the mean force for all instrument applications was 171 Newtons and the average force duration was 0.963 milliseconds. The investigators reported that force-producing instrumentation exhibited less variation in absolute force and force duration compared to manual techniques. On average, the standard deviation for all manual applications represented 16 % of the applied force and 23 % of the mean force duration. For all instrument applications, the standard deviation represented 4 % of the mean applied force and 5 % of the mean force duration. The investigators noted, however, that there were significant differences in absolute force between operators using the same instrument. The investigator concluded that the use of an instrument would be expected to reduce human inconsistency and result in reduced variation in magnitude and duration of force among operators. This study is limited in that it did not report on clinical outcomes of manual versus instrumented manipulation in humans.

A number of clinical studies have evaluated the effect of Activator treatment on autonomic functions (Yates et al, 1988; Peterson, 1997; Roy et al, 2008; Roy et al, 2009; Roy et al, 2013; Roffers et al, 2015); the clinical significance and implications of these findings, however, is uncertain. Yates et al (1988) examined the effectiveness of the Activator technique compared to sham Activator treatment in lowering blood pressure or no treatment in 21 patients with elevated blood pressure, finding that the Activator treatment significantly reduced blood pressure in the short-term. The investigators concluded that further research is necessary to evaluate the long-term effectiveness of treatment. "While spinal manipulative therapy appears to be effective in producing a temporary reduction in blood pressure immediately after treatment, the effect of such treatment in reducing blood pressure over a period of days or weeks is unknown and warrants further investigation."

Roffers et al (2015) conducted a randomized controlled trial to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on blood pressure and pulse rate on normotensive and hypertensive persons. After internal review board approval and informed consent, 290 subjects who met the inclusion criteria were randomly assigned to one of three groups: control (N = 95; no treatment, no placebo); placebo treatment (N = 96; sham adjustment with inactive device); or Activor treatment (N = 99). Subjects were seated in a relaxing climate-controlled room for a minimum of 15 min prior to obtaining a baseline blood pressure (BP) (systolic and diastolic) and pulse rate (PR) measurement with an electronic oscillometric BP monitor. The subjects were then moved to chairs stationed according to the study group in which they were assigned. Subjects had another BP and PR measured (anxiety BP and PR measurements) after being called upon for active treatment, placebo treatment, or no treatment at all. Active treatment involved the use of the Activator IV adjusting instrument to correct subluxations detected according to the Activator Methods Chiropractic Technique for thoracic vertebrae T5 to T1. Placebo treatment was performed with an Activator II10 adjusting instrument in the off position which mimics all aspects of the treatment that is administered when in the on position but no manipulative force is delivered. Following active treatment (or placebo treatment or no treatment), subjects had their BP and PR measured once again. Subjects ranged in age from 18 to 100 years old (mean age = 52) and 66% of them were female. Systolic and diastolic BP decreased significantly ( p = 0.0001) in the active treatment group, whereas no significant changes occurred in the placebo treatment and control groups. Similarly, PR decreased significantly ( p = 0.0001) in the active treatment group, whereas no significant changes occurred in the placebo treatment and control groups.

Using a digitized infrared segmental thermometry (DIST) to measure cutaneous temperature (CT), Roy, et al. assessed the effect the Activator on cutaneous temperature during 2 different time recording periods (TRPs). Sixty-six healthy subjects (36 women and 30 men) without acute low back conditions or symptoms were recruited. Subjects were randomly divided into 2 groups based on the length of the acclimatization period (8 or 30 minutes; TRP(8) and TRP(30), respectively). In turn, each recording period group was divided into 3 subgroups (n = 11 per subgroup): treatment, sham, and control subgroups. Bilateral DIST was conducted at L-4 (TRP(30)) and L-5 (TRP(8)) using infrared cameras (Subluxation Station Insight 7000; Chiropractic Leadership Alliance, Mahwah, NJ). Before treatment (t(-0.5)), the TRP(8) CT was significantly different between the ipsilateral and the contralateral sides for all subgroups. At 10 minutes (t(10)) after intervention, CT increased significantly (P < .05) for the treatment group but not for the sham and control groups. In contrast, there were no significant differences in the TRP(30) CT before treatment between the ipsilateral and the contralateral sides; but at t(10), CT was significantly (P < 0.05) greater for all 3 subgroups compared with preintervention CT. The investigators concluded that contacting the skin with the instrument with (treatment group TRP(30)) or without (sham group TRP(30)) a thrust with a sustained pressure stronger than the loading principle taught in the Activator protocol or a thrust respecting the standard loading principle (treatment group TRP(8)) of the instrument produced a CT cooling immediately after the adjustment. The investigators also observed that when contacting the skin with the instrument with a thrust respecting the standard loading principle (treatment group TRP(8)) of the instrument, it produced a secondary cooling at t(5) followed by a rewarming at t(10). Finally, contacting the skin with the instrument without a thrust and respecting the standard loading principle (sham TRP(8)) of the instrument did not produce a CT change.

Roy et al (2009) examined heart rate variability (HRV) in the presence or the absence of pain in the lower back, while receiving one chiropractic treatment at L5 from either a manually assisted mechanical force (Activator) or a traditional diversified technique spinal manipulation. A total of 51 participants were randomly assigned to a control (n = 11), 2 treatment, or 2 sham groups (n = 10 per group). Participants underwent an 8-minute acclimatizing period. The HRV tachygram (RR interval) data were recorded directly into a Suunto watch. We analyzed the 5-minute pretreatment and posttreatment intervals. The spectral analysis of the tachygram was performed with Kubios software. All groups decreased in value except the control group that reacted in the opposite direction, when comparing the pretests and posttests for the high-frequency component. The very low frequency increased in all groups except the control group. The low frequency decreased in all groups except the sham pain-free group. The low frequency-high frequency ratio decreased in the treatment pain group by 0.46 and in the sham pain-free group by 0.26. The low frequency-high frequency ratio increase was 0.13 for the sham pain group, 0.04 for the control group, and 0.34 for the treatment pain-free group. The mean RR increased by 11.89 milliseconds in the sham pain-free group, 18.65 milliseconds in the treatment pain group, and 13.14 milliseconds in the control group. The mean RR decreased in the treatment pain-free group by 1.75 milliseconds and by 0.01 milliseconds in the sham pain group. The investigators concluded that adjusting the lumbar vertebrae affected the lumbar parasympathetic nervous system output for this group of participants.

Roy et al (2013) reported on the effects of Activator treatment on paraspinal cutaneous temperature (PCT) for subjects with chronic low back pain and compare these PCT findings to subjects without chronic low back pain. Two groups were created, a symptomatic treatment group (subjects with chronic low back pain, n = 11, 7 males, 4 females) and an asymptomatic, nontreatment group (asymptomatic subjects, n = 10, 6 males, 4 females). Outcomes included the modified Oswestry questionnaire and PCT measurements in the prone position after an 8-minute acclimation period. The treatment group received 9 Activator treatments over 2 weeks. Reevaluation was done 2 weeks after the initial evaluation for both groups. The preintervention Oswestry results (29.8% ± 11.8%) for the treatment group were higher than the asymptomatic group (10.2% ± 10.6%). The postintervention Oswestry results for the treatment group were 14.20 % ± 11.5%. The resulting Cohen's effect size of the spinal manipulation on the Oswestry evaluation is 0.58. The preintervention PCT showed higher temperature for the nontreatment group compared with the treatment group. Comparing the levels associated with low back pain, the nontreatment group PCT was stable, varying from 0.01°C to 0.02°C, whereas the treatment group PCT varied from 0.10°C to 0.18°C. The treatment group postintervention PCT showed an increase in temperature after the 9 visits; however, this did not reach the values of the asymptomatic group. The authors concluded that the percutanous temperature (PCT) readings for subjects with chronic low back pain were lower than the asymptomatic, nontreatment group. The PCT temperature of the treatment group increased after 9 treatments.

In a randomized controlled trial, Peterson et al (1997) assessed the effect of spinal manipulation with Activator upon visual analog scale (VAS) and pulse rates as proxies for the intensity of emotional arousal in phobic subjects exposed to a threat stimulus. The authors found significant decreases in VAS scores but no significant change in pulse rates after Activator treatment. Eighteen phobic community college student volunteers randomized into treatment and control groups. Visual analog scale (VAS) and pulse rates were obtained in response to the subjects' viewing their phobogenic stimulus. Spinal manipulation was performed while the subjects experienced emotional responses. Manual muscle testing was utilized to ascertain the associated spinal segments and involved emotion. Data were analyzed using analysis of variance for a repeated measures experimental design and Least Significant Differences (LSDs) for mean comparisons. Baseline, preintervention and postintervention pulse rates were not statistically different for the control and treatment groups (p = .0807). VAS postintervention mean for the spinal manipulation group was significantly lower than the control means (p = .05) and from its corresponding preintervention mean (p = .001). The authors stated that the mechanism for this effect of Activator on VAS is not known.

Other clinical studies of Activator have focused on intermediate endpoints of inflammatory markers (Roy et al, 2010), EMG activity (Keller and Colloca, 2010; Yu et al, 2010), and pressure pain thresholds (Yu et al, 2010); the relationship of these intermediates to patient outcomes is uncertain. Roy et al (2010) reported on the responses of inflammatory markers interleukin-6 (IL-6) and C-reactive protein (CRP) after a series of 9 Activator treatments. Twenty-one participants were assigned to a treatment or a control group. Only the treatment group received 9 Activator treatments. Pre- and post-intervention measures were recorded for blood samples for detection of proinflammatory cytokines IL-6 and CRP. The investigators reported that mediators of inflammation (IL-6 and high-sensitivity CRP) were modified by the intervention received in the treatment group, and the effect size demonstrated a tendency toward the control group values. The authors reported that the 9 Activator treatments caused the mediators of inflammation to present a normalization response in individuals suffering from chronic low back pain. The main limitation of this study is that it reports on intermediate endpoints; the relationship of these endpoints to patient outcomes is unknown.

In a prospective clinical trial, Keller and Colloca (2010) assessed whether Activator treatment affects paraspinal muscle strength as assessed through use of surface electromyography (sEMG). Forty subjects with low back pain (LBP) participated in the study. Twenty patients with LBP (9 females and 11 males with a mean age of 35 years and 51 years, respectively) and 20 age- and sex-matched sham-spinal manipulative therapy (SMT)/control LBP subjects (10 females and 10 males with a mean age of 40 years and 52 years, respectively) were assessed. Twenty consecutive patients with LBP (SMT treatment group) performed maximum voluntary contraction (MVC) isometric trunk extensions while lying prone on a treatment table. Surface, linear-enveloped sEMG was recorded from the erector spinae musculature at L3 and L5 during a trunk extension procedure. Patients were then assessed through use of the Activator Methods Chiropractic Technique protocol, during which time they were treated through use of Activator treatment. The Activator treatment was followed by a dynamic stiffness and algometry assessment, after which a second or post-MVC isometric trunk extension and sEMG assessment were performed. Another 20 consecutive subjects with LBP were assigned to one of two other groups, a sham-Activator treatment group and a control group. The sham-Activator treatment group underwent the same experimental protocol with the exception that the subjects received a sham-Activator treatment and dynamic stiffness assessment. The control group subjects received no spinal manipulation treatment, stiffness assessment, or algometry assessment intervention. Within-group analysis of MVC sEMG output (pre-Activator treatment vs post-Activator treatment sEMG output) and across-group analysis of MVC sEMG output ratio (post-Activator sEMG/pre-Activator sEMG output) during MVC was performed through use of a paired observations t test (POTT) and a robust analysis of variance (RANOVA), respectively. Surface, linear-enveloped EMG recordings during isometric MVC trunk extension were used as the primary outcome measure. Nineteen of the 20 patients in the Activator treatment group showed a positive increase in sEMG output during MVC (range, -9.7% to 66.8%) after the active Activator treatment and stiffness assessment. The Activator treatment group showed a significant (POTT, P < 0.001) increase in erector spinae muscle sEMG output (21% increase in comparison with pre-Activator treatment levels) during MVC isometric trunk extension trials. There were no significant changes in pre-treatment or vs post-treatment MVC sEMG output for the sham-Activator (5.8% increase) and control (3.9% increase) groups. Moreover, the sEMG output ratio of the Activator treatment group was significantly greater (robust analysis of variance, P = 0.05) than either that of the sham-Activator treatment group or that of the control group. The investigators concluded that the results of this preliminary clinical trial demonstrated that Activator treatment results in a significant increase in sEMG erector spinae isometric MVC muscle output. These findings indicate that altered muscle function may be a potential short-term therapeutic effect of Activator treatment, and they form a basis for a randomized, controlled clinical trial to further investigate acute and long-term changes in low back function.

Yu et al (2010) investigated the effects of Activator treatment targeted to the low-back region on changes in pressure pain thresholds (PPTs) and basal electromyographic activity (BEA) in asymptomatic participants. A repeated-measures, single-blind, randomized trial was conducted on 30 participants, 19 men and 11 women (mean age, 24.5±3.9 years), without a current history of low-back pain. Each participant attended all 2 treatment group sessions and received Activator treatment or a sham manipulation procedure. Bilateral PPT levels over L5-S1 zygapophyseal joints, L5 dermatome, and first dorsal interossei in the hand and bilateral BEA of low back and neck region were assessed pre- and posttreatment by an assessor blinded to the treatment allocation of the participant. A 3-way analysis of variance with time (pre-post) and side (ipslateral, contralateral to the intervention) as within-group variable and intervention (manipulation or sham) as between-group variable was used to evaluate changes in PPT. A paired sample t test was used to analyze the differences between pre- and posttreatment in BEA. The group vs time interaction was statistically significant for PPT irrespective of the site tested or the side treated. Participants receiving the Activator treatment experienced greater improvement in PPT when compared with the control group. Paired sample t tests for BEA only show an immediate decrease in BEA of the paraspinal muscle on the pelvic deficiency side of the low-back region.

In a case series study (n = 9), Devocht et al (2003) reported that the symptoms of temporomandibular disease improved following a course of treatment using the Activator methods. The authors concluded that further investigation of this type of chiropractic treatment for patients with the articular type of temporomandibular disease is warranted. Moreover, Fuhr and Menke (2005) stated that the Activator Adjusting Instrument may be a clinically useful tool, but its ultimate scientific validation requires testing using sophisticated research models in the areas of neurophysiology, biomechanics, and statistical analysis. This is in agreement with the observation of Polkinghorn (1998) who noted that instrument-delivered adjustments (i.e., the Activator Adjusting Instrument) may provide benefit in cases of cervical disc protrusion in which manual manipulation causes an exacerbation of the symptoms or is contraindicated altogether. The author concluded that further study in this area should be made via large scale studies organized in an academic research setting.

Devocht et al (2013) reported on a pilot study of the feasibility of conducting a larger trial to evaluate chiropractic treatment of temporomandibular disorders (TMDs). The authors stated that this pilot study was a necessary step to prepare for a larger study that will provide clinicians with information that should be helpful when discussing treatment options for patients with TMD. The authors assigned 80 participants randomly into one of the following four groups, all of which included a comprehensive self-care program: reversible interocclusal splint therapy (RIST), Activator treatment, sham Activator treatment and self-care only. They made assessments at baseline and at month 2 and month 6, including use of the Research Diagnostic Criteria for Temporomandibular Disorders. The authors screened 721 potential participants and enrolled 80 people; 52 participants completed the six-month assessment. The adjusted mean change in current pain over six months, as assessed on the 11-point numerical rating scale, was 2.0 (95 percent confidence interval, 1.1-3.0) for RIST, 1.7 (0.9-2.5) for self-care only, 1.5 (0.7-2.4) for Activator treatment and 1.6 (0.7-2.5) for sham Activator treatment. The authors also assessed bothersomeness and functionality. The authors found the study design and methodology to be manageable. They stated that they had gained substantial knowledge to aid in conducting a larger study. The authors stated that Activator treatment, RIST and self-care should be evaluated in a future comparative effectiveness study.

In a prospective, randomized, comparative clinical trial, Shearar et al (2005) examined the effect of instrument-delivered compared with traditional manual-delivered thrust chiropractic adjustments in the treatment of sacroiliac joint syndrome. A total of 60 patients with sacroiliac syndrome were randomized into 2 groups of 30 subjects. Each subject received 4 chiropractic adjustments over a 2-week period and was evaluated at 1-week follow-up. One group received side-posture, high-velocity, low-amplitude chiropractic adjustments; the other group received mechanical-force, manually-assisted chiropractic adjustments using an Activator Adjusting Instrument (Activator Methods International, Ltd, Phoenix, AZ). No significant differences between groups were noted at the initial consultation for any of the outcome variables. Statistically significant improvements were observed in both groups from the 1st to 3rd, 3rd to 5th, and 1st to 5th consultations for improvements (p < 0.001) in mean numerical pain rating scale 101 (group 1, 49.1 to 23.4; group 2, 48.9 to 22.5), revised Oswestry Low Back Pain Disability Questionnaire (group 1, 37.4 to 18.5; group 2, 36.6 to 15.1), orthopedic rating score (group 1, 7.6 to 0.6; group 2, 7.5 to 0.8), and algometry measures (group 1, 4.8 to 6.5; group 2, 5.0 to 6.8) for first to last visit for both groups. The authors concluded that the findings of this study indicated that a short regimen of either mechanical-force, manually-assisted or high-velocity, low-amplitude chiropractic adjustments were associated with a beneficial effect of a reduction in pain and disability in patients diagnosed with sacroiliac joint syndrome. Neither mechanical-force, manually-assisted nor high-velocity, low-amplitude adjustments were found to be more effective than the other in the treatment of this patient population.

Gemmell and Miller (2010) reported on a trial comparing manipulation, segmental mobilization and Activator treatment of mechanical neck pain that was stopped because of poor recruitment. A pragmatic randomised clinical trial was undertaken. Patients who met eligibility criteria were randomised into three groups. One group was treated using specific segmental high velocity low amplitude manipulation (diversified), another by specific segmental mobilisation, and a third group by the Activator instrument. All three groups were also treated for any myofascial distortions and given appropriate exercises and advice. Participants were treated six times over a three-week period or until they reported being pain free. The primary outcome measure for the study was Patient Global Impression of Change (PGIC); secondary outcome measures included the Short-Form Health Survey (SF-36v2), the neck Bournemouth Questionnaire, and the numerical rating scale for pain intensity. Participants also kept a diary of any pain medication taken and noted any perceived adverse effects of treatment. Outcomes were measured at four points: end of treatment, and 3, 6, and 12 months thereafter. Between January 2007 and March 2008, 123 patients were assessed for eligibility, of these 47 were considered eligible, of which 16 were allocated to manipulation, 16 to the Activator instrument and 15 to the mobilisation group. Comparison between the groups on the PGIC adjusted for baseline covariants did not show a significant difference for any of the endpoints. Within group analyses for change from baseline to the 12-month follow up for secondary outcomes were significant for all groups on the Bournemouth Questionnaire and for pain, while the mobilisation group had a significant improvement on the PCS and MCS subscales of the SF-36v2. Finally, there were no moderate, severe, or long-lasting adverse effects reported by any participant in any group. The authors stated that, although there were no significant dfferences between groups, the small size of the study may have left it underpowered to detect clinically significant differences in safety and efficacy between groups. The authors concluded that this pragmatic trial should be repeated with a larger sample size.

Schneider et al (2010) reported on an observational prospective cohort study to explore the treatment effect of Activator versus manual manipulation for acute low back pain. Ninety-two patients with a history of acute low back pain were recruited from 3 private chiropractic offices, 2 of which used manual lumbar manipulation and 1 used Activator as their primary modes of treatment. The chiropractors used their "treatment-as-usual" protocols for a maximum of 8 visits or 4 weeks, whichever occurred first. Primary outcome measures were changes in Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI) scores from baseline to 4 weeks. The linear regression models were adjusted for baseline NPRS and ODI scores, age, and treatment expectancy. Comparison of baseline characteristics did not show any significant differences between the groups except for age (38.4 vs 49.7 years, P < .001) and treatment expectancy (5.7 vs 6.3, P = .003). Linear regression revealed significantly lower NPRS scores in the manual manipulation group at 4 weeks (beta = -1.2; 95% confidence interval, -2.1 to -.28) but no significant difference in ODI scores between the 2 groups at 4 weeks (beta = 1.5; 95% confidence interval, -8.3 to 2.4). Treatment expectancy was found to have a significant main effect on both NPRS and ODI scores at 4 weeks. Exploratory analysis of the clinical patterns of care between the clinicians revealed significant differences in treatment frequency, duration, modality, and radiograph use between the 2 cohorts. These differences may have confounded the comparison of outcomes between groups treated with Activator versus manual manipulation. The authors concluded that this study highlights the challenges inherent with conducting research that allows for "treatment as usual." The authors stated that the data and experience derived from this investigational study will be used to design a future randomized clinical trial in which tighter controls will be imposed on the treatment protocol.

Schneider et al (2015) reported on a randomized controlled trial comparing manual-thrust manipulation (MTM) versus mechanical-assisted manipulation (MAM) with Activator; and manipulation versus usual medical care (UMC). The authors stated that MTM is a common treatment for low back pain (LBP), and that claims that MAM is an effective alternative to MTM have yet to be substantiated. A total of 107 adults with onset of LBP within the past 12 weeks were randomized to 1 of 3 treatment groups: MTM, MAM, or UMC. Outcome measures included the Oswestry LBP Disability Index (0-100 scale) and numeric pain rating (0-10 scale). Participants in the manipulation groups were treated twice weekly during 4 weeks; subjects in UMC were seen for 3 visits during this time. Outcome measures were captured at baseline, 4 weeks, 3 months, and 6 months. Linear regression showed a statistically significant advantage of MTM at 4 weeks compared with MAM (disability = -8.1, P = 0.009; pain = -1.4, P = 0.002) and UMC (disability = -6.5, P = 0.032; pain = -1.7, P < 0.001). Responder analysis, defined as 30% and 50% reductions in Oswestry LBP Disability Index scores revealed a significantly greater proportion of responders at 4 weeks in MTM (76%; 50%) compared with MAM (50%; 16%) and UMC (48%; 39%). Similar between-group results were found for pain: MTM (94%; 76%); MAM (69%; 47%); and UMC (56%; 41%). No statistically significant group differences were found between MAM and UMC, and for any comparison at 3 or 6 months. The investigators concluded that MTM provides greater short-term reductions in self-reported disability and pain scores compared with UMC or MAM with Activator. The authors stated that "these results contradict prior assumptions of therapeutic equivalence between manual thrust and mechanical-assisted types of manipulation."

Commenting on this study by Schneider et al, Guevarra and Seffinger (2015) noted that one major limitation is that other outcome measures were not examined, particularly nonprescription medication use. They commented that, because all participants were allowed to use analgesics and nonsteroidal anti-inflammatory medications, it would be interesting to see if any differences between treatment groups existed or if any changes occurred in use over time. Another limitation of this study by Schneider, et al. noted by Guevarra and Seffinger is the lack of a sham therapy or control group. "However, the findings in this study are promising in that MTM [manual thrust manipulation] can be considered part an effective treatment plan for patients with LBP."

Fuhr et al (2005) reviewed the literature on the Activator Adjusting Instrument (AAI) and Activator Methods Chiropractic Technique of clinical assessment. Online resources were searched including Index to Chiropractic Literature, EBSCO Online, MANTIS, CHIROLARS, CINAHL, eJournals, Ovid, MDConsult, Lane Catalog, SU Catalog, and Pubmed. Relevant peer-reviewed studies, commentaries, and reviews were selected. Studies fell into 2 major content areas: instrument adjusting and the analysis system for therapy application. Studies were categorized by research content type: biomechanical, neurophysiological, and clinical. Each study was reviewed in terms of contribution to knowledge and critiqued with regard to quality. The authors found more than 100 studies related to the AAI and the technique, including studies on the instrument's mechanical effects, and a few studies on clinical efficacy. With regard to the analysis, there is evidence for good reliability on prone leg-length assessment, but to date, there is only 1 study evaluating the Activator Methods Chiropractic Technique analysis. The authors found that a body of basic science and clinical research has been generated on the AAI since its first peer-reviewed publication in 1986. The authors stated that the Activator analysis may be a clinically useful tool, but its ultimate scientific validation requires testing using sophisticated research models in the areas of neurophysiology, biomechanics, and statistical analysis.

Huggins et al (2012) reported on a systematic evidence review of Activator treatment in the treatment of musculoskeletal disorders, finding no significant difference with manual techniques. The authors, however, found only 8 clinical trials that sought to determine the clinical effectiveness of the Activator treatment. The authors noted that none of the clinical trials included in the systematic evidence review were randomized clinical trials; and all the studies used small study populations, ranging from 8 to 92 subjects. Moreover, not all studies were adequately controlled with respect to both subject and examiner blinding, with 5 of the studies being assigned a 0 out of 5. An additional limitation was that all but one study failed to either strategize or adjust for relevant baseline characteristics. Due to the lack of long-term follow-up care and the use of a single treatment intervention, contamination and co-intervention grading had to be assumed in 4 of the 8 studies which may have further influenced the overall quality of these studies. A further limitation was that 7 of the 8 studies utilized a previously established patient base as study subjects, thus introducing the possible confounding factors of treatment expectancy and type II errors.

The Atlas orthogonal technique is an upper-cervical, spinal-corrective procedure that is intended to restore a person’s balance and stimulate the natural-healing capabilities normally present in the body. Unlike other chiropractic procedures, there is no twisting or cracking involved. Besides correcting spinal issues, the Atlas orthogonal technique is thought to help with various conditions such as arthritis, migraine headaches, asthma, and fibromyalgia. However, there is a lack of evidence regarding the clinical value of this technique.

The Blair technique is a specific system of analyzing and adjusting the upper cervical vertebrae. Attention is given to the atlas and axis (the first 2 cervical vertebrae) since they are the most freely moveable vertebrae in the spinal cord and the ones most commonly mis-aligned. The objective of the Blair technique is not to diagnose or treat diseases or conditions, but to analyze and correct vertebral subluxations such that the body can repair and maintain health from within. However, there is a lack of evidence regarding the clinical value of this technique.

Biogeometric integration has been described as a conceptual understanding that enhances chiropractors' knowledge of the human body. Seminars on biogeometric integration provide an understanding of the innate geometry of the body and force dynamics surrounding the creation and release of subluxations. The philosophy, science, and art of chiropractic are examined from a post-Newtonian point of view, providing the opportunity to express and understand chiropractic in accord with contemporary science. Through understanding of the innate geometry of the body, chiropractors are thought to be able to more effectively and gently release the subluxation and assess the effectiveness of the adjustment. The geometric understanding of the body also serves to bridge the gap between the many techniques of chiropractic by providing a common language and understanding from which to converse. However, there is a lack of evidence regarding the clinical value of this approach.

The Whitcomb Technique, advocated by Paul Whitcomb, allegedly can cure patients with fibromyalgia. It entails a quick neck manipulation, 3 times a day, 5 days a week, for at least 2 months. The number of neck manipulations ranged from 60 to 143. However, there is a lack of evidence regarding the clinical value of this method.

There is inadequate evidence of the effectiveness of Neuro Emotional Technique (NET) for attention deficit hyperactivity disorder (ADHD) or other indications. Karpouzis et al (2009) stated that an abundance of literature is dedicated to research for the treatment of ADHD. Most, is in the area of pharmacological therapies with less emphasis in psychotherapy and psychosocial interventions and even less in the area of complementary and alternative medicine (CAM). The use of CAM has increased over the years, especially for developmental and behavioral disorders, such as ADHD. Almost 2/3 of parents with children with ADHD have used CAM. Medical evidence supports a multi-disciplinary approach (i.e., pharmacological and psychosocial) for the best clinical outcomes. The NET, a branch of chiropractic, was designed to address the biopsychosocial aspects of acute and chronic conditions including non-musculoskeletal conditions. Anecdotally, it has been suggested that ADHD may be managed effectively by NET. A randomized, placebo-controlled, double-blind, clinical trial was designed to assess the effectiveness of NET on a cohort of children with medically diagnosed ADHD. Children aged 5 to 12 years who met the inclusion criteria were randomized to one of three groups. The control group continued on their existing medical regimen and the intervention and placebo groups had the addition of the NET and sham NET protocols added to their regimen, respectively. These 2 groups attended a clinical facility twice-weekly for the first month and then once-monthly for 6 months. The Conners' Parent and Teacher Rating Scales (CRS) were used at the start of the study to establish baseline data and then in 1-month and in 7-month time, at the conclusion of the study. The primary outcome measures chosen were the Conners' ADHD Index and Conners' Global Index. The secondary outcome measures chosen were the DSM-IV: Inattentive, the DSM-IV: Hyperactive-Impulsive, and the DSM-IV: Total subscales from the Conners' Rating Scales, monitoring changes in inattention, hyperactivity and impulsivity. Calculations for the sample size were set with a significance level of 0.05 and the power of 80 %, yielding a sample size of 93. The authors noted that the present study should provide information as to whether the addition of NET to an existing medical regimen can improve outcomes for children with ADHD.

Bablis et al (2009) described the profile of patients presenting to a private chiropractic clinic specializing in NET; and identified trends in the presentation of symptoms from these patients. A total of 761 consecutive new patients presented to a large, multi-doctor chiropractic clinic in which practitioners all adopt a similar philosophical paradigm and practice NET From January 2005 to December 2005, self-referred patients completed a new patient questionnaire, in which they self-reported 1 primary complaint for why they were visiting the practitioner. Pre-determined patient information was entered manually into a database and basic descriptive statistics extracted. Overall, 67.3 % of participants were female and 32.6 % of the participants were between the ages of 31 and 40; 54.8 % of patients presented with a primary musculoskeletal complaint and 36.0 % a non-musculoskeletal complaint. Of the musculoskeletal complaints, 40.8 % of patients presented with back pain, 20.9 % with neck pain and 11.5 % with shoulder pain. The most common form of non-musculoskeletal complaint was immune and recurrent infections (13.9 %), stress and anxiety (12.8 %) and depression (10.9 %). 41.4 % of participants reported a first time complaint, however, of the patients who had had the presenting complaint before 60.7 % reported as having the complaint for greater than 1 year. Musculoskeletal and non-musculoskeletal participants had similar pain profiles. The authors concluded that this retrospective analysis is the first comprehensive description of the scope of NET patients and their presenting complaints. The patient profile of this NET clinic has a higher degree of non-musculoskeletal patients than that usually reported in non-NET chiropractic offices, and other forms of chiropractic previously described in the literature. They stated that further cross-sectional research is required to determine if this particular clinic is indicative of all NET practices and whether the presenting symptoms, especially the non-musculoskeletal, are resolved with NET.

There is insufficient evidence to support the use of chiropractic in treatment of non-neuromusculoskeletal conditions in children. In a review Chiropractic Diagnosis and Management of Non-musculoskeletal Conditions in Children and Adolescents, Ferrance and Miller (2010) noted that a great deal has been published in the chiropractic literature regarding the response, or lack thereof, of various common pediatric conditions to chiropractic care. The majority of that literature is of low scientific value (i.e., case reports or case series). The purpose of this review was to summarize the literature from the point of view of clinicians, rather than researchers, and to discuss some additional detail of the conditions themselves. Databases searched were PubMed, Mantis, Index to Chiropractic Literature, and CINAHL. Keywords were chiropractic paired with colic, crying infant, nocturnal enuresis, asthma, otitis media and ADHD. Most of the published literature centers around case reports or series. The more scientifically rigorous studies show conflicting results for colic and the crying infant, and there is little data to suggest improvement of otitis media, asthma, nocturnal enuresis or attention deficit hyperactivity disorder. The authors concluded that the efficacy of chiropractic care in the treatment of non-musculoskeletal disorders has yet to be definitely proven or disproven, with the burden of proof still resting upon the chiropractic profession.

There is a paucity of evidence of the effectiveness of spinal manipulation for treatment of headaches. Vernon et al (2009) stated that tension-type headache (TTH) is the most common headache experienced by adults in Western society. Only 2 clinical trials of spinal manipulation for adult TTH have been reported, neither of which was fully controlled. In 1 trial, spinal manipulation was compared to amitriptyline. This trial was stopped prematurely due to poor recruitment. The purposes of this study were to

describe the trial protocol, as it contained several novel features,
report the limited data set obtained from sample of completed subjects, and
discuss the problems that were encountered in conducting this study.

Sufferers of TTH with more than 10 headaches per month were randomly assigned to 4 groups:

real cervical manipulation + real amitriptyline,
real cervical manipulation + placebo amitriptyline,
sham cervical manipulation + real amitriptyline, and
sham cervical manipulation + placebo amitriptyline.

A baseline period of 4 weeks was followed by a treatment period of 14 weeks. The primary outcome was headache frequency obtained from a headache diary in the last 28 days of the treatment period. A total of 19 subjects completed the trial. In the unadjusted analysis, a statistically significant main effect of chiropractic treatment was obtained (-2.2 [-10.2 to 5.8], p = 0.03), which was just below the 3-day reduction set for clinical importance. As well, a clinically important [corrected] effect of the combined therapies was obtained (-9 [-20.8 [corrected] to 2.9], p = 0.13), but this did not achieve statistical significance. In the adjusted analysis, neither the main effects of chiropractic nor amitriptyline were statistically significant or clinically important; however, the effect of the combined treatments was -8.4 (-15.8 to -1.1), which was statistically significant (p = 0.03) and reached the criterion for clinical importance. The authors concluded that although the sample size was smaller than initially required, a statistically significant and clinically important effect was obtained for the combined treatment group. There are considerable difficulties with recruitment of subjects in such a trial. They stated that this trial should be replicated with a larger sample.

Haas et al (2010) presented a preliminary model to identify the effects of expectancy of treatment success and the patient-provider encounter (PPE) on outcomes in an open-label randomized trial of spinal manipulation for cervicogenic headache. A total of 80 subjects with chronic cervicogenic headache (CGH) were randomized to 4 groups: 2 levels of treatment dose (8 or 16) and 2 levels of therapy from a chiropractor (spinal manipulation or light massage). Providers were instructed to have equal enthusiasm for all care. Structural equation modeling with standardized path coefficients (beta) was used in a path analysis to identify the effects of patient expectancy and the PPE on CGH pain. The model included monthly pain from baseline to 12 weeks. Expectancy and PPE were evaluated on Likert scales. The patient-provider encounter was measured as patient perception of chiropractor enthusiasm, confidence, and comfort with care. Baseline patient expectancy was balanced across groups. The PPE measures were balanced across groups and consistent over the 8-week treatment period. Treatment and baseline pain had the strongest effects on pain outcomes (|beta| = 0.46 to 0.59). Expectations had little effect on pain (abs value(beta) < 0.15). The patient-provider encounter had a weak effect on pain (abs value(beta) = 0.03 to 0.27) and on subsequent confidence in treatment success (abs value(beta) = 0.09 and 0.12). The authors concluded that encouraging equipoise in the PPE and balancing expectancy across treatment groups may protect against some confounding related to the absence of blinding in a randomized controlled trial of pain. In this trial, their effects were found to be small relative to the effects of treatment and baseline values.

In a multi-center, prospective, randomized, placebo-controlled, and blinded study, Borusiak and colleagues (2010) examined the effectiveness of cervical spine manipulation in children and adolescents with suspected cervicogenic headaches. A total of 52 children and adolescents (21 boys and 31 girls) aged 7 to 15 years were assigned either to placebo or true manipulation with another 2-month follow-up. Main outcome measures were percentage of days with headache, total duration of headache, days with school absence due to headache, consume of analgesics, intensity of headache. These investigators did not find a significant difference between the placebo group and the true manipulation group with respect to the defined main outcome measures. The authors concluded that they were unable to show an efficacy of cervical spine manipulation in 52 children and adolescents with suspected cervicogenic headaches.

There is little reliable evidence to support the use of chiropractic in treatment of idiopathic dizziness. In a pilot study, Hawk et al (2009) collected preliminary information on the effect of a limited and extended course of chiropractic care on balance, chronic pain, and associated dizziness in a sample of older adults with impaired balance. These investigators conducted a randomized trial targeting a sample size of 30, comparing 2 schedules of chiropractic care to a no-treatment group. Group 1 (limited schedule) was treated for 8 weeks, group 2 (extended schedule) was treated for 8 weeks and then once-monthly for 10 months, and group 3 received no treatment. Assessments were made at baseline and 1, 2, 6, and 12 months later. The primary outcome was changed in the Berg Balance Scale (BBS) from baseline to 1 year. Changes in the Pain Disability Index (PDI) and Dizziness Handicap Index (DHI) were also measured. A total of 34 patients were enrolled, 13 in group 1, 15 in group 2, and 6 in group 3. Only 5 had baseline BBS scores less than 45, indicating increased risk for falls. There were no treatment-related adverse events. Nine patients dropped out by 1 year. No significant differences within or between groups in median BBS from baseline to 12 months were observed. Median PDI scores improved more from baseline to 1 year in group 2 compared with groups 1 and 3 (p = 0.06, Kruskal-Wallis test). For the 9 patients with dizziness, a clinically significant improvement in DHI scores of groups 1 and 2 was observed at 1 month and remained lower than baseline thereafter; this was not true of group 3. The authors concluded that further investigation of the possible benefit of chiropractic maintenance care (extended schedule) for balance and pain-related disability is feasible and warranted, as well as both limited and extended schedules for patients with idiopathic dizziness.

In a pilot study, Lewis et al (2006) examined if the active therapeutic movement (ATM2) can decrease low back pain (LBP), increase range of motion (ROM) and what the mechanism may be that is responsible for any decrease in pain. The ATM2 was shown to be effective in reducing LBP complaints although not significantly better than the abdominal hollowing exercise. Subjects were all students in their 20’s and the overall presenting pain levels were low to start. The fact that the ATM2 did not significantly decrease LBP more than the mat exercise is not surprising as abdominal hollowing exercises are often prescribed for patients with LBP. The ATM2 was shown to be effective in increasing lumbar ROM whereas the mat exercise was not. The ATM2 did not appear to impact central nervous system re-programming of the transverse abdominus (TrA) muscle based on this procedure. However, studies that have looked at TrA timing have utilized needle electromyography (EMG) and this study used surface EMG that only can pick up the reflection of TrA activity. In addition, the software program used was difficult to read the extremely short time values necessary to accurately measure timing of the trunk muscles. Based on the results of this pilot study, the ATM2 has potential for helping patients with LBP and warrants further study.

The Koren Specific Technique (KST) appears to be a new system of analysis in chiropractic. With the KST method, the adjustment is generally made with an instrument called the "Arthrostim" although finger pressure can also be used. The KST allegedly opens up a new horizon on the analysis and correction of health problems by accessing the binary information of the holographic body, which supposedly enables a trained practitioner to access information about a patient's physiology that otherwise would not be available. However, there is a lack of evidence regarding the effectiveness of this approach.

Ernst (2009) noted that some chiropractors claim that spinal manipulation is an effective treatment for infant colic. The author performed a systematic review aimed at evaluating the evidence for this claim. Four databases were searched and 3 randomized controlled trials met all the inclusion criteria. The totality of this evidence fails to show the effectiveness of this treatment. The author concluded that the above claim is not based on convincing data from rigorous clinical trials.

According to the International Chiropractic Pediatric Association (Ohm, 2006), the Webster protocol is a specific chiropractic sacral analysis and diversified adjustment. The goal of the adjustment is to reduce the effects of sacral subluxation/SI joint dysfunction. In so doing neuro-biomechanical function in the pelvis is facilitated. Cohain (2007) stated that techniques for turning a term breech baby include

external cephalic version (ECV) using hands and ultrasound only;
acupuncture point stimulation, by needle or moxibustion;
chiropractic "Webster" technique;
hypnotherapy; and
special exercises.

The author noted that 50 % of breech fetuses at 34 weeks will turn by themselves to head down by 38 weeks. Therefore, to be considered effective, a technique for turning breech must turn the baby and keep it turned more than 50 % of the time. Only ECV with an experienced practitioner has been documented to have a greater than 50 % success rate at 37 weeks; in 95 % of cases the head stays down. Furthermore, an UpToDate review on "Overview of breech presentation" (Hofmeyr, 2011) does not mention the use of chiropractic or the Webster Technique.

Ernst (2011) stated that many chiropractors believe that chiropractic treatments are effective for gastro-intestinal (GI) disorders. In a systematic review, the author evaluated the evidence from controlled clinical trials supporting or not supporting this notion. A total of 6 electronic databases were searched for relevant studies. No limits were applied to language or publication date. Prospective, controlled, clinical trials of any type of chiropractic treatment for any type of GI problem, except infant colic, were included. Only 2 trials were found – 1 was a pilot study, and the other had reached a positive conclusion; however, both had serious methodological flaws. The author concluded that there is no supportive evidence that chiropractic is an effective treatment for GI disorders.

The FAKTR (Functional and Kinetic Treatment with Rehab) Approah was developed about 9 years ago by Greg Doerr, D.C. and Tom Hyde, D.C. who began to experiment with treating soft tissue/fascial disorders through the use of instruments. Both physicians were trained in a variety of soft tissue techniques including instrument-assisted soft tissue mobilization (IASTM) and decided to incorporate their previous training into a concept that included function and treatment of the kinetic chain while utilizing various forms of rehabilitation at the same time. They also incorporated treatment in the position of provocation (pain, loss of range of motion, feeling of tightness within the fascia/soft tissues) and during motion. The FAKTR approach incorporates all of the above variations to evaluate and treat soft tissue/fascial conditions. However, there is a lack of evidence regarding the effectiveness of the FAKTR Approach.

According to the Family Chiropractic Wellness Center, the Gonzalez Rehabilitation Technique (GRT) is a collection of patented techniques that evaluate and restore major nerves in the body. This approach supposedly makes the body function more efficiently by allowing previously wasted energy to be used for healing. The GRT does not treat any conditions. More importantly, the GRT focuses on "up-regulating" the nerves that may be associated to a condition so that the body heals itself; GRT is a technique that improves the way the nerves activate. An analogy is that if one can visualize a muscle or organ being controlled by a dimmer switch, one may be able to understand how 10 individuals with the exact same injury/condition can each have a unique level of dysfunction. In many cases the muscle or organ may be only slightly dimmed with minimal symptoms of pain, decreased range of motion, decreased strength and impaired organ function. And in other instances it may be completely dimmed, resulting in debilitating pain, paralysis, and poor organ function. In any case, the GRT is similar regardless of the level of dysfunction. The GRT can be directed to specific nerve groups to help patients with certain conditions. For example: the foot is controlled at the S1, L5 and L4 spinal levels. If anyone has ANY condition affecting the foot (e.g., broken foot, diabetic ulcer on the foot, hammer toes, heel spurs, plantar fasciitis, and sprained ankle, etc.), one or more of these nerves are affected and by "up-regulating" these nerves the function will return and the conditions/symptoms improve if not completely disappear. The GRT practitioners are trained in various methods of correction including manual, instrument and light therapy techniques; and they report success of this approach in treating patients with various conditions including but not limited to:

Autoimmune diseases: Guillain-Barre syndrome, multiple sclerosis, rheumatoid arthritis
Brain injury: Bell’s palsy, paralysis, speech and swallowing dysfunction, stroke
Joint and bone injury: Broken bones, decreased joint space, ligament tears, post-surgery
Spinal cord injury: Paralysis, sensory and motor injury
Sports injury: Decreased range of motion, muscle and joint pain.

There is a lack of evidence regarding the effectiveness of GRT in the treatment of pain, musculoskeletal disorders and other conditions.

Dynamic spinal visualization is a general term used to describe several different imaging technologies, including digital motion x-ray and videofluoroscopy, also known as cineradiography.

Digital motion x-ray (DMX) is a video-based fluoroscopy system, involving the use of either film x-ray or computer-based x-ray ‘snapshots’ taken in sequence. The procedure is performed with the patient standing and actively moving in a weight bearing position within the system. Film x-rays are digitized into a computer for manipulation while computer-based x-rays are automatically created in a digital format. The digitized images are then put in order using a computer program and played on a video monitor, creating a moving image of the body. DMX allows clinicians to view the spine and extremity articulations in real-time at 30 exposures per second, and evaluate several aspects of the body’s structures such as intervertebral flexion and extension to determine the presence or absence of abnormalities.

Videofluoroscopy and cineradiography are different names for the same procedure that utilizes a technique called fluoroscopy to create real-time video images of internal structures of the body. Unlike standard x-rays that take a single picture at one point in time, fluoroscopy works more like a video camera, providing motion pictures of the inside the of body. The findings can be displayed in real time on a video monitor or recorded to allow computer analysis or evaluation at a later time.

The Therapeutic (Wobble) Chair (Pettibon System, Inc., Chehalis, WA) is a patented, height adjustable stool with a specially-designed seat. The seat provides 360 degrees of rotation, 40 degrees of side-to-side flexion and 35 degrees of front-to-back flexion on a universal type joint to facilitate all possible combinations of exercise motion needed for lumbar disc mobility, re-hydration, nutrition delivery, and waste elimination. However, there is insufficient evidence to support the clinical value of the Therapeutic (Wobble) Chair.

Morningstar (2006) stated that lumbar disc herniation is a problem frequently encountered in manual medicine. While manual therapy has shown reasonable success in symptomatic management of these cases, little information is known how manual therapy may affect the structure and function of the lumbar disc itself. In cases where lumbar disc herniation is accompanied by radicular symptoms, electrodiagnostic testing has been used to provide objective clinical information on nerve function. The author examined the treatment rendered for a patient with lower extremity neurological deficit, as diagnosed on electrodiagnostic testing. Patient was treated using spinal manipulation and exercises performed on a Pettibon Wobble Chair, using electrodiagnostic testing as the primary outcome assessment. An elderly male patient presented to a private spine clinic with right-sided foot drop. He had been prescribed an ankle-foot orthosis for this condition. All sensory, motor, and reflex findings in the right leg and foot were absent. This was validated on prior electromyography and nerve conduction velocity testing, performed by a board certified neurologist. Patient was treated using spinal manipulation twice-weekly and wobble chair exercises 3 times daily for 90 days total. Following this treatment, the patient was referred for follow-up electrodiagnostic studies. Significant improvements were made in these studies as well as self-rated daily function. The author concluded that motion-based therapies, as part of a comprehensive rehabilitation program, may contribute to the restoration of daily function and the reversal of neurological insult as detected by electrodiagnostic testing. The author noted that electrodiagnostic testing may be a useful clinical tool to evaluate the progress of chiropractic patients with lumbar disc herniation and radicular pain syndromes. This was a single case study and findings were confounded by combinational use of spinal manipulation and Pettibon wobble chair.

In contrast to other hands-on modalities, where the practitioner imposes correction on the client through manipulation, the Bowen Technique facilitates the body in healing itself, with minimal intervention. Because of the subtle nature of the Bowen Technique, and the body's continuing response to it over several days thereafter, other forms of manipulative therapy are discouraged for up to 5 days after a session, as they may interfere with the efficacy of the work. However, there is a lack of evidence regarding the effectiveness of the Bowen Technique.

Alcantara et al (2014) stated that constipation compromises the health-related quality of life of children. Chiropractic is a popular alternative therapy for children with constipation. These investigators performed this integrative review of the literature to inform clinical practice. This integrative review of the literature began with an examination of the databases PubMed [1966 to 2013], MANTIS [1964 to 2013] and Index to Chiropractic Literature [1984 to 2013]. The search terms used were "constipation", "chronic constipation", and "bowel dysfunction" in the context of chiropractic. Inclusion criteria involved the care of children 0 to 18 years old published in the English language. These researchers found 14 case reports, 1 case series, and 1 review of the literature. A number of chiropractic techniques were described with treatment varying according to the diagnosis, chief complaint and age of the patient. The authors concluded that this integrative review revealed the need for more research and theoretical development on the care of children with constipation.

Advanced Biostructural Correction is a chiropractic technique that allows for full spinal correction so the body can work the way it was designed to. This approach analyzes and adjusts the spine and body that, over time, allows the body to unwind and recover from its previous injuries and distortions, and thus achieve its optimal, healthy state. This is achieved by first checking for and releasing tension in the meningeal system, followed by adjusting those vertebrae and other bones that the body cannot retrieve or re-position on its own. The Advanced Biostructural Correction protocol also corrects the forward spinal lean that has been pulling on the brainstem and spinal cord. However, there is a lack of evidence regarding the clinical effectiveness of this approach.

Positional Release Therapy

Kelencz et al (2011) evaluated the treatment of the cervico-brachialgia by Positional Release Therapy (PRT). The present work studied 6 patients aged 44 to 63 (1 male and 5 female) who presented tension in the trapezius upper portion fibers. All patients were submitted to 10 sessions of 30 minutes each. The electromyography (EMG) was collected on the first and 10th day of treatment. The results demonstrated a progressive decrease of pain in each session. The tension was evaluated by the EMG analysis, which showed the relations between time of treatment and less pain. The authors concluded that with these results, it was possible to verify quantitatively the effectiveness of the PRT in the improvement of life quality. This was a small (n = 6), uncontrolled study; its findings need to be validated by well-designed studies.

Ghanbari et al (2012) compared the effectiveness of trigger points' management by PRT and routine medical therapy in treatment of tension type headache (TTH). A total of 30 patients with active trigger points in cervical muscles entered to the study. They were randomly assigned to PRT or medical therapy group. Headache frequency, intensity and duration and tablet count were recorded by use of a daily headache diary. Sensitivity of trigger points was assessed by numeric pain intensity and by use of a digital force gauge (FG 5020). Both groups showed significant reduction in headache frequency and duration and tablet count after treatment phase. However, the reduction of study variables was persisted only in PRT group after follow-up phase. There was no significant reduction in headache intensity, neither in PRT and nor in medication group. Sensitivity of trigger points was significantly reduced. In comparison of the 2 study groups, there was no significant difference in headache frequency, intensity, duration and tablet count (p > 0.05). The authors concluded that both procedures were equally effective according to the study. Thus, PRT can be a treatment choice for patients with TTH. The findings of this small study (presumably n = 15 for the PRT group and n = 15 for the medical therapy group) did not provide strong evidence that PRT is effective for the treatment of TTH.

Mohamadi et al (2012) reported the case of a 47-year old female patient with TTH treated by PRT for her trigger points. She had a constant dull headache, which continued all the day for 9 months. A physiotherapist evaluated the patient and found active trigger points in her cervical muscles. Then, she received PRT for her trigger points. After 3 treatment sessions, the patient's headache stopped completely. During the 8 months following the treatment she was without pain, and did not use any medication. The authors concluded that PRT was effective in treating TTH. They stated that these findings suggested that PRT could be an alternative treatment to medication in patients with TTH if the effectiveness of that can be confirmed by further studies.

Alonso-Blanco and colleagues (2012) stated that recent evidence suggested that active trigger points (TrPs) in neck and shoulder muscles contribute to TTH. Active TrPs within the sub-occipital, upper trapezius, sternocleidomastoid, temporalis, superior oblique and lateral rectus muscles have been associated with chronic and episodic TTH. It seems that the pain profile of this headache may be provoked by referred pain from active TrPs in the posterior cervical, head and shoulder muscles. In fact, the presence of active TrPs has been related to a higher degree of sensitization in TTH. Different therapeutic approaches have been proposed for proper TrP management. Preliminary evidence indicated that inactivation of TrPs may be effective for the management of TTH, particularly in a subgroup of patients who may respond positively to this approach. Different treatment approaches targeted to TrP inactivation were discussed in the current paper, focusing on TTH. The authors concluded that new studies are needed to further delineate the relationship between muscle TrP inactivation and TTH.

In a pilot study, Bodes-Pardo et al (2013) determined feasibility of a clinical trial to measure the effects of manual therapy on sternocleidomastoid active TrPs in patients with cervicogenic headache (CeH). A total of 20 patients (7 male and 13 female; mean ± SD age of 39 ± 13 years), with a clinical diagnosis of CeH and active TrPs in the sternocleidomastoid muscle were randomly divided into 2 groups. One group received TrP therapy (manual pressure applied to taut bands and passive stretching), and the other group received simulated TrP therapy (after TrP localization no additional pressure was added, and inclusion of longitudinal stroking but no additional stretching). The primary outcome was headache intensity (numeric pain scale) based on the headaches experienced in the preceding week. Secondary outcomes included neck pain intensity, cervical range of motion (CROM), pressure pain thresholds (PPT) over the upper cervical spine joints and deep cervical flexors motor performance. Outcomes were captured at baseline and 1 week after the treatment. Patients receiving TrP therapy showed greater reduction in headache and neck pain intensity than those receiving the simulation (p < 0.001). Patients receiving the TrP therapy experienced greater improvements in motor performance of the deep cervical flexors, active CROM, and PPT (all, p < 0.001) than those receiving the simulation. Between-groups effect sizes were large (all, standardized mean difference, p > 0.84). The authors concluded that the findings of this study provided preliminary evidence that a trial of this nature is feasible. The preliminary findings showed that manual therapy targeted to active TrPs in the sternocleidomastoid muscle may be effective for reducing headache and neck pain intensity and increasing motor performance of the deep cervical flexors, PPT, and active CROM in individuals with CeH showing active TrPs in this muscle. They stated that studies including greater sample sizes and examining long-term effects are needed.

In a randomized clinical trial, Llamas-Ramos et al (2014) compared the effects of TrP dry needling (DN) and TrP manual therapy (MT) on pain, function, pressure pain sensitivity, and cervical range of motion in subjects with chronic mechanical neck pain. A total of 94 patients (mean ± SD age of 31 ± 3 years; 66 % female) were randomized into a TrP DN group (n = 47) or a TrP MT group (n = 47). Neck pain intensity (11-point numeric pain rating scale), cervical range of motion (ROM), and pressure pain thresholds (PPTs) over the spinous process of C7 were measured at baseline, post-intervention, and at follow-ups of 1 week and 2 weeks after treatment. The Spanish version of the Northwick Park Neck Pain Questionnaire was used to measure disability/function at baseline and the 2-week follow-up. Mixed-model, repeated-measures analyses of variance (ANOVAs) were used to determine if a time-by-group interaction existed on the effects of the treatment on each outcome variable, with time as the within-subject variable and group as the between-subject variable. The ANOVA revealed that participants who received TrP DN had outcomes similar to those who received TrP MT in terms of pain, function, and cervical ROM. The 4-by-2 mixed-model ANOVA also revealed a significant time-by-group interaction (p < 0.001) for PPT: patients who received TrP DN experienced a greater increase in PPT (decreased pressure sensitivity) than those who received TrP MT at all follow-up periods (between-group differences: post-treatment, 59.0 kPa; 95 % confidence interval [CI]: 40.0 to 69.2; 1-week follow-up, 69.2 kPa; 95 % CI: 49.5 to 79.1; 2-week follow-up, 78.9 kPa; 95 % CI: 49.5 to 89.0). The authors concluded that the results of this clinical trial suggested that 2 sessions of TrP DN and TrP MT resulted in similar outcomes in terms of pain, disability, and cervical ROM. Those in the TrP DN group experienced greater improvements in PPT over the cervical spine. They stated that future trials are needed to examine the effects of TrP DN and TrP MT over long-term follow-up periods.

Preventive or Maintenance Chiropractic Manipulation

Preventive or maintenance chiropractic manipulation has been defined as elective health care that is typically long-term, by definition not therapeutically necessary but is provided at preferably regular intervals to prevent disease, prolong life, promote health and enhance the quality of life. This care may be provided after maximum therapeutic improvement, without a trial of withdrawal of treatment, to prevent symptomatic deterioration or it may be initiated with patients without symptoms in order to promote health and to prevent future problems.

Preventive services may include patient education, home exercises, and ergonomic postural modification. The appropriateness and effectiveness of chiropractic manipulation as a preventive or maintenance therapy has not been established by clinical research and is not covered.

Supportive care has been defined as treatment for patients who have reached maximum therapeutic benefit, but who fail to sustain benefit and progressively deteriorate when there are periodic trials of treatment withdrawal. Continuation of chiropractic care is considered medically necessary until maximum therapeutic benefit has been reached, when the patient fails to progress clinically between treatments, or when pre-injury/illness status has been reached. Once the maximum therapeutic benefit has been achieved, continuing chiropractic care is not considered medically necessary and thus is not covered.

Active corrective care is ongoing treatment, rendered after the patient has become symptomatically and objectively stable, to prevent a recurrence of a patient's condition by correcting underlying abnormal spinal biomechanics that appear to be the cause of the initial injury. The efficacy of active corrective care is not supported by scientific evidence and is not covered.

The Cox Decompression Manipulation/Technique

In a case report, Kruse and Cambron (2011) described a patient with an L5/S1 posterior surgical fusion who presented to a chiropractic clinic with subsequent LBP and leg pain and was treated with Cox decompression manipulation. A 55-year old male postal clerk presented to a private chiropractic practice with complaints of pain and spasms in his low back radiating down the right buttock and leg . His pain was a 5 of 10, and ODI score was 18 %. The patient reported a previous surgical fusion at L5/S1 for a grade 2 spondylolytic spondylolisthesis. Radiographs revealed surgical hardware extending through the pedicles of L5 and S1, fusing the posterior arches. Treatment consisted of ultrasound, electric stimulation, and Cox decompression manipulation (flexion distraction) to the low back. After 13 treatments, the patient had a complete resolution of his symptoms with a pain score of 0 of 10 and an ODI score of 2 %. A 2-year follow-up revealed continued resolution of the patient's symptoms. The authors concluded that the Cox chiropractic decompression manipulation may be an option for patients with LBP subsequent to spinal fusion; more research is needed to verify these results.

In a case report, Joachim (2014) described combined treatment utilizing Cox distraction manipulation and guided rehabilitation for a patient with spine pain and post-surgical C6 to C7 fusion with spondylotic myelopathy and L5 to S1 radiculopathy. A 38-year old man presented to a chiropractic clinic with neck pain and a history of an anterior cervical spine plate fusion at C6 to C7 after a work-related accident 4 years earlier. He had signs and symptoms of spondolytic myelopathy and right lower back, right posterior thigh pain and numbness. The patient was treated with Cox technique and rehabilitation. The patient experienced a reduction of pain on a numeric pain scale from 8/10 to 3/10. The patient was seen a total of 12 visits over 3 months. No adverse effects (AEs) were reported. The author concluded that a patient with a prior C6 to C7 fusion with spondylotic myelopathy and concurrent L5 to S1 radiculopathy improved after a course of rehabilitation and Cox distraction manipulation. Moreover, they stated that further research is needed to establish its effectiveness.

The IntraDiscNutrosis Program

According to the Disc Institute, the IntraDiscNutrosis program is a non-invasive, innovative treatment that can repair seriously damaged discs, providing lasting relief where other treatments have failed.

However, there is a lack of evidence regarding the effectiveness of the IntraDiscNutrosis program.

Management of Menopause-Associated Vasomotor Symptoms

The 2015 position statement of the North American Menopause Society (NAMS) updated and expanded the NAMS evidence-based position on non-hormonal management of menopause-associated vasomotor symptoms (VMS). The North American Menopause Society enlisted clinical and research experts in the field and a reference librarian to identify and review available evidence; 5 different electronic search engines were used to cull relevant literature. Using the literature, experts created a document for final approval by the NAMS Board of Trustees. Non-hormonal management of VMS is an important consideration when hormone therapy is not an option, either because of medical contraindications or a woman's personal choice. Non-hormonal therapies include lifestyle changes, mind-body techniques, dietary management and supplements, prescription therapies, and others. The costs, time, and effort involved as well as AEs, lack of long-term studies, and potential interactions with medications all need to be carefully weighed against potential effectiveness during decision-making. The updated position statement stated that clinicians need to be well-informed about the level of evidence available for the wide array of non-hormonal management options currently available to mid-life women to help prevent underuse of effective therapies or use of inappropriate or ineffective therapies. The North American Menopause Society recommended cognitive-behavioral therapy and, to a lesser extent, clinical hypnosis, which have been shown to be effective in reducing VMS. Paroxetine salt is the only non-hormonal medication approved by the Food and Drug Administration (FDA) for the management of VMS, although other selective serotonin reuptake/norepinephrine reuptake inhibitors, gabapentinoids, and clonidine showed evidence of efficacy. The NAMS recommended with caution some therapies that may be beneficial for alleviating VMS (e.g., weight loss, mindfulness-based stress reduction, the S-equol derivatives of soy isoflavones, and stellate ganglion block), and noted that additional studies of these therapies are needed. The NAMS did not recommend the following unproven therapies – cooling techniques, avoidance of triggers, exercise, yoga, paced respiration, relaxation, over-the-counter supplements and herbal therapies, acupuncture, calibration of neural oscillations, and chiropractic interventions – because there are negative, insufficient, or inconclusive data regarding the effectiveness of these approaches for managing VMS.

Management of Headaches (e.g., Cervicogenic Headache and Migraine)

Chaibi and colleagues (2015) stated that cervicogenic headache (CEH) is a secondary headache that affects 1.0 to 4.6 % of the population. Although the costs are unknown, the health consequences are substantial for the individual; especially considering that they often suffers chronicity. Pharmacological management has no or only minor effect on CEH. In a single-blinded, placebo-controlled, randomized clinical trial (RCT), these researchers evaluated the effectiveness of chiropractic spinal manipulative therapy (CSMT) for CEH. According to the power calculations, these investigators aimed to recruit 120 participants to the RCT. Participants will be randomized into 1 of 3 groups:

CSMT,
placebo (sham manipulation), and
control (usual non-manual management).

The RCT consists of 3 stages:

1 month run-in,
3 months intervention, and
follow-up analyses at the end of intervention and 3, 6 and 12 months.

Primary end-point is headache frequency, while headache duration, headache intensity, headache index (HI) (frequency × duration × intensity) and medicine consumption are secondary end-points. Primary analysis will assess a change in headache frequency from baseline to the end of intervention and to follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Due to 2 group-comparisons, the results with p values below 0.025 will be considered statistically significant. For all secondary end-points and analyses, the significance level of 0.05 will be used. The results will be presented with the corresponding p values and 95 % CIs. To the authors’ knowledge, this is the first prospective manual therapy 3-armed single-blinded placebo-controlled RCT to be conducted for CEH. Current RCTs suggested effectiveness in headache frequency, duration and intensity. However a firm conclusion requires clinical single-blinded, placebo-controlled RCTs with few methodological shortcomings. The present study design adheres to the recommendations for pharmacological RCTs as far as possible and follows the recommended clinical trial guidelines by the International Headache Society.

Chaibi and associates (2017) examined the effectiveness of CSMT for migraineurs. This was a prospective, 3-armed, single-blinded, placebo, RCT of 17 months duration including 104 migraineurs with at least 1 migraine attack per month. The RCT was conducted at Akershus University Hospital, Oslo, Norway. Active treatment consisted of CSMT, whereas placebo was a sham push maneuver of the lateral edge of the scapula and/or the gluteal region. The control group continued their usual pharmacological management. The RCT consisted of a 1-month run-in, 3 months intervention and outcome measures at the end of the intervention and at 3, 6 and 12 months follow-up. The primary end-point was the number of migraine days per month, whereas secondary end-points were migraine duration, migraine intensity and HI, and medicine consumption. Migraine days were significantly reduced within all 3 groups from baseline to post-treatment (p < 0.001). The effect continued in the CSMT and placebo group at all follow-up time points, whereas the control group returned to baseline. The reduction in migraine days was not significantly different between the groups (p > 0.025 for interaction). Migraine duration and HI were reduced significantly more in the CSMT than the control group towards the end of follow-up (p = 0.02 and p = 0.04 for interaction, respectively); AEs were few, mild and transient. Blinding was strongly sustained throughout the RCT. The authors concluded that it was possible to conduct a manual-therapy RCT with concealed placebo, and the effect of CSMT observed in this study was probably due to a placebo response.

Moore and colleagues (2017a) evaluated research studies on the prevalence of patient use of manual therapies for the treatment of headache and the key factors associated with this patient population. This critical review of the peer-reviewed literature identified 35 papers reporting findings from new empirical research regarding the prevalence, profiles, motivations, communication and self-reported effectiveness of manual therapy use amongst those with headache disorders. While available data was limited and studies had considerable methodological limitations, the use of manual therapy appeared to be the most common non-medical treatment utilized for the management of common recurrent headaches. The most common reason for choosing this type of treatment was seeking pain relief. While a high percentage of these patients likely continue with concurrent medical care, around 50 % may not be disclosing the use of this treatment to their medical doctor. The authors concluded that there is a need for more rigorous public health and health services research in order to evaluate the role, safety, utilization and financial costs associated with manual therapy treatment for headache. Primary healthcare providers should be mindful of the use of this highly popular approach to headache management in order to help facilitate safe, effective and coordinated care.|

Moore and colleagues (2017b) evaluated the prevalence and characteristics of chiropractors who frequently manage patients with migraine. A national cross-sectional survey of chiropractors collected information on practitioner characteristics, clinical management characteristics and practice settings. A secondary analysis was conducted on 1,869 respondents who reported on their migraine caseload to determine the predictors associated with the frequent management of patients with migraine. A large proportion of chiropractors report having a high migraine caseload (HMC) (n = 990; 53.0 %). The strongest factors predicting a chiropractor having a HMC include the frequent treatment of patients with axial neck pain (odds ratio [OR] = 2.89; 95 % CI: 1.18 to 7.07), thoracic pain (referred/radicular) (OR = 2.52; 95 % CI: 1.58 to 3.21) and non-musculoskeletal disorders (OR = 3.06; 95 % CI: 2.13 to 4.39). The authors concluded that several practice-setting and clinical management characteristics are associated with chiropractors managing a HMC. These findings raised key questions about the therapeutic approach to chiropractic migraine management that deserves further examination. They stated that there is a need for more primary research to evaluate the approach to headache and migraine management provided by chiropractors and to understand the prevalence, burden and co-morbidities associated with migraine found within chiropractic patient populations.

Treatment of Pregnancy-Related Low Back Pain, Pelvic Girdle Pain, or Combination Pain

In a RCT, Gausel and colleagues (2017) examined the outcome of chiropractic management for a subgroup of pregnant women with dominating one-sided pelvic girdle pain (PGP). The study population was recruited from a prospective longitudinal cohort study of pregnant women. Women reporting pelvic pain (PP), and who were diagnosed with dominating one-sided PGP after a clinical examination, were invited to participate in the intervention study. Recruitment took place either at 18 weeks, or after an SMS-tracking up to week 29. The women were randomized into a treatment group or a control group. The treatment group received chiropractic treatment individualized to each woman with regards to treatment modality and number of treatments. The control group was asked to return to conventional primary health care. The primary outcome measure was new occurrence of full time and/or graded sick leave due to PP and/or LBP. Secondary outcome measures were self-reported PP, physical disability and general health status. Proportion of women reporting new occurrence of sick leave were compared using Chi squared tests. Differences in secondary outcome measures were estimated using linear regression analyses. A total of 56 women were recruited, and 28 of them were randomized into the treatment group, and 28 into the control group. There was no statistically significant difference in sick leave, PP, disability or general health status between the 2 groups during pregnancy or after delivery. The authors concluded that the study did not demonstrate superiority of chiropractic management over conventional care for dominating one-sided PGP during pregnancy. However, the analyses revealed wide confidence intervals containing both positive and negative clinically relevant effects. They stated that further studies on the effect of chiropractic management for specific subgroups of PGP are needed.

In a systematic review, Weis and colleagues (2020) examined the effectiveness of chiropractic care options commonly used for pregnancy-related LBP, PGP, or combination pain for both experienced practitioners and students of chiropractic. These researchers included procedures that were commonly used by chiropractors and not requiring additional certifications. Outcomes were self-reported changes in pain or disability. They used the Scottish Intercollegiate Guideline Network checklists to evaluate outcomes. For strength of evidence, these investigators employed the adapted version of the U.S. Preventive Services Task Force (USPSTF) criteria as described in the United Kingdom report. A total of 50 articles were included from 18 systematic reviews, 30 RCTs, and 2 cohort studies. Pregnancy-related LBP (7 systematic reviews and 12 RCTs): moderate, favorable evidence for electrotherapy and osteopathic manipulative therapy; inconclusive, favorable strength for chiropractic care, exercise, and support devices; and inconclusive, unclear strength for spinal manipulative therapy. Pregnancy-related PGP (4 systematic reviews and 4 RCTs): inconclusive, favorable strength for exercise; and inconclusive, unclear evidence for patient education, information, and support devices. Pregnancy-related LBP or PGP (13 systematic reviews and 12 RCTs): moderate, unclear evidence for complementary and alternative medicine; moderate, unclear evidence for exercise; inconclusive, favorable evidence for multi-modal care, patient education, and physiotherapy; and inconclusive, unclear strength for spinal manipulative therapy, osteopathic manipulative therapy, and support devices. The authors concluded that although there is a lack of conclusive evidence, many of the interventions had moderate or unclear but favorable evidence.

Furthermore, an UpToDate review on “Maternal adaptations to pregnancy: Musculoskeletal changes and pain” (Bermas, 2021) states that “A systematic review of eight trials on complementary and alternative medicine for low back pain and/or pelvic pain in pregnancy reported reduced visual analog pain scores for patients treated with acupuncture based on three trials. However, variations in the duration of treatment, gestational age at treatment, and control groups limit the ability to make definitive conclusions or practice recommendations. In the same systematic review, osteopathy and chiropractic modalities were not associated with pain reduction, but the data were based on one trial for each treatment group”.

Other Experimental and Investigational Indications of Chiropractic

Saleh and associates (2015) stated that chiropractic is a complementary medicine that has been growing increasingly in different countries over recent decades. It addresses the prevention, diagnosis and treatment of the neuro-musculoskeletal system disorders and their effects on the whole body health. These investigators evaluated the effectiveness of chiropractic in the treatment of different diseases. They searched scientific electronic databases (e.g., Cochrane, Medline, Google Scholar, and Scirus) and all systematic reviews in the field of chiropractic were obtained. Reviews were included if they were specifically concerned with the effectiveness of chiropractic treatment, included evidence from at least 1 clinical trial, included randomized studies and focused on a specific disease. The research data including the article's first author's name, type of disease, intervention type, number and types of research used, meta-analysis, number of participants, and overall results of the study, were extracted, studied and analyzed. A total of 23 chiropractic systematic reviews were found, and 11 articles met the defined criteria. The results showed the influence of chiropractic on improvement of neck pain, shoulder and neck trigger points, and sport injuries. In the cases of asthma, autism spectrum disorder, back pain, carpal tunnel syndrome, fibromyalgia, gastro-intestinal problems, and infant colic, there was no conclusive scientific evidence. The authors concluded that there is heterogeneity in some of the studies and also limited number of clinical trials in the assessed systematic reviews; conducting comprehensive studies based on more reliable study designs are highly recommended.

Infant Colic

Carnes and colleagues (2018) carried out a systematic review and meta-analyses to examine the effect of manual therapy for healthy but unsettled, distressed and excessively crying infants and to provide information to help clinicians and parents to make informed-decisions regarding care. These investigators reviewed published peer-reviewed primary research articles in the last 26 years from 9 databases (Medline Ovid, Embase, Web of Science, Physiotherapy Evidence Database, Osteopathic Medicine Digital Repository , Cochrane (all databases), Index of Chiropractic Literature, Open Access Theses and Dissertations and Cumulative Index to Nursing and Allied Health Literature). The inclusion criteria were: manual therapy (by regulated or registered professionals) of unsettled, distressed and excessively crying infants who were otherwise healthy and treated in a primary care setting. Outcomes of interest were: crying, feeding, sleep, parent-child relations, parent experience/satisfaction and parent-reported global change. A total of 19 studies were selected for full review: 7 RCTs, 7 case-series studies, 3 cohort studies, 1 service evaluation study and 1 qualitative study. They found moderate strength evidence for the effectiveness of manual therapy on: reduction in crying time (favorable: -1.27 hours per day (95 % CI: -2.19 to -0.36)), sleep (inconclusive), parent-child relations (inconclusive) and global improvement (no effect). The risk of reported adverse events (AEs) was low: 7 non-serious events per 1,000 infants exposed to manual therapy (n = 1,308), and 110 per 1,000 in those not exposed. The authors concluded that they found moderate favorable evidence for the reduction in crying time in infants receiving manual therapy care (around 1 hour per day), but this may change with further research evidence. These investigators still do not know if this result is meaningful to parents or if the reduction is due to the manual therapy component of care or other aspects of care. For other outcomes, the strength of evidence was low and inconclusive. Moreover, these researchers stated that the outcomes for parental satisfaction and confidence were under-researched, and they did not find much data about these. Collecting parent outcomes may provide more informative data about the active components of care. They stated that a well-powered RCT with parental blinding, blinded assessment of reported outcomes, testing both non-specific and manual therapy effects of manual therapist care is needed to supplement research in this area.

The authors stated that this study had 2 drawbacks. First, there was 1 Chinese paper that was selected for full paper review. These investigators translated this article, but they were unable to fully interpret and understand the treatment given and the outcomes that related to Chinese Traditional Medicine energy points. In other words, the therapeutic paradigm presented was beyond the authors’ knowledge from a Western medicine perspective. Second, inclusion criteria were specific to this population of interest (i.e., thriving infants who were inexplicably unsettled, distressed and excessively crying who were treated in primary care). This symptom-based approach to selection allowed the inclusion of studies relating to various diagnoses (e.g., breast-feeding, gastric and behavioral problems). However, this latitude could also be interpreted as a weakness, since definitions of unsettledness, distress and excessive crying and otherwise healthy were not always clear. Perhaps a more stringent, universally accepted definition of "colic" is needed. Thus, these researchers may have failed to include some studies due to the authors’ descriptions of their populations.

Chiropractic Management of Depression

Chu and Ng (2018) reported the case of a 44-year old school teacher who experienced long-term relief from tension-type headache (TTH) and major depression following chiropractic treatment. It is well-recognized that psychiatric co-morbidity and suicide risk are commonly found in patients with painful physical symptoms such as chronic headache, backache, or joint pain. Recent studies indicated that autonomic dysfunction plays a role in the pathogenesis of TTHs and depressive disorders. The autonomic nervous system is mainly controlled by reflex centers located in the spinal cord, brain stem, and hypothalamus. This report high-lighted the rewarding outcomes from spinal adjustment in certain neuropsychiatric disorders. The authors concluded that long-term results of chiropractic adjustment in this particular case were very favorable. Moreover, they stated that further studies with larger groups are needed to better clarify the role of chiropractic.

Chiropractic Management of Dizziness/Vertigo

Kendall and colleagues (2018) noted that dizziness in the elderly is a risk factor for falls. Neck pain is associated with dizziness and responds favorably to neck manipulation. However, it is unknown if chiropractic intervention including instrument-assisted manipulation of the neck in the elderly with neck pain could also improve dizziness. This parallel 2-arm pilot trial was conducted in Melbourne, Australia over 9 months (October 2015 to June 2016). Participants aged 65 to 85 years, with self-reported chronic neck pain and dizziness, were recruited from the general public through advertisements in local community newspapers and via Facebook. Participants were randomized using a permuted block method to 1 of 2 groups: Activator II-instrument-assisted cervical and thoracic spine manipulation plus a combination of: light massage; mobilization; ROM exercises; and home advice about the application of heat, or Sham-Activator II-instrument-assisted manipulation (set to zero impulse) plus gentle touch of cervical and thoracic spinal regions. Participants were blinded to group allocation. The interventions were delivered weekly for 4 weeks. Assessments were conducted 1 week pre- and post-intervention. Clinical outcomes were assessed blindly and included: dizziness (dizziness handicap inventory [DHI]); neck pain (neck disability index [NDI]); self-reported concerns of falling; mood; physical function; and treatment satisfaction. Feasibility outcomes included recruitment rates, compliance with intervention and outcome assessment, study location, success of blinding, costs and harms. Out of 162 enquiries, 24 participants were screened as eligible and randomized to either the chiropractic (n = 13) or sham (n = 11) intervention group. Compliance was satisfactory with only 2 participants lost to follow-up; thus, post-intervention data for 12 chiropractic intervention and 10 sham intervention participants were analyzed; blinding was similar between groups. Mild harms of increased spinal pain or headaches were reported by 6 participants. Costs amounted to AUD$ 2,635 per participant. The data showed a trend favoring the chiropractic group in terms of clinically-significant improvements in both NDI and DHI scores. Sample sizes of n = 150 or n = 222 for dizziness or neck pain disability as the primary outcome measure, respectively, would be needed for a fully powered trial. The authors concluded that recruitment of participants in this setting was difficult and expensive. However, a larger trial may be feasible at a specialized dizziness clinic within a rehabilitation setting. Compliance was acceptable and the outcome measures used were well accepted and responsive.

Furthermore, an UpToDate review on "Treatment of vertigo" (Furman and Barton, 2018) does not mention chiropractic / spinal manipulation as a therapeutic option.

Chiropractic Management of Female Infertility

Budgell and Yee (2018) noted that debate concerning chiropractic management of female infertility occurs largely in the absence of reference to the extant literature. These investigators carried out a scoping review of primary data publications on the chiropractic management of female infertility based on searches of the Index to Chiropractic Literature and PubMed, supplemented by papers from one author's archive. A total of 10 articles, all case studies, met the review's inclusion criteria and documented the experiences of 11 women (mean age of 31 years; mean period of infertility 3 years). Pregnancy occurred, on average, after 5 months of treatment with spinal manipulation and adjunctive modalities. No adverse events (AEs) were reported. There are very few original data articles documenting responses of infertile females treated with spinal manipulation. The authors concluded that in the absence of a robust body of primary data literature, the use of spinal manipulation for the management of female infertility should be approached with caution.

Furthermore, an UpToDate review on "Treatments for female infertility" (Kuohung and Hornstein, 2018) does not mention chiropractic / spinal manipulation as a therapeutic option.

The NUCCA Procedure

According to the National Upper Cervical Chiropractic Association, the NUCCA procedure frees the nervous system of interference by using a precise, non-invasive, gentle touch technique. The NUCCA procedure brings several generations of clinical research to correcting the serious problem of the atlas subluxation complex. By using precise and objective x-ray views of the head and neck, mathematical measurement and analysis are made of the misalignment. Once the misalignment is understood by the doctor, there is no need for further x-rays because correlating the relationship between posture and upper cervical misalignment allows posture to then be used thereafter to judge alignment. There is also often less need for repeated corrections because returning the bones of the neck to a normal position also normalizes function in the body. To begin, most doctors offer a consultation so that you can experience the office and make sure the people and process are a comfortable match to your needs. This gives the doctor a chance to hear a bit about your situation, make some measurements, and discuss the potential of NUCCA treatment. The supine leg check, which shows leg length inequality, is the basic standard to determine if you have an upper cervical misalignment. Many doctors use an Anatometer, a NUCCA endorsed measuring tool that evaluates standing posture. Some doctors may use other devices including the Gravity Stress Analyzer and hip calipers. Any other health problems, injuries, motor vehicle accidents, surgeries, along with other treatment programs, which include diagnostic tests and x-rays, are also evaluated and assessed. After this initial process, the doctor will begin the steps necessary in determining if your spinal column is significantly misaligned or out of balance.

There is insufficient evidence to support the use of the NUCCA procedure for the management of various health conditions.

Bakris et al (2007) noted that anatomical abnormalities of the cervical spine at the level of the Atlas vertebra are associated with relative ischemia of the brainstem circulation and increased blood pressure (BP). Manual correction of this mal-alignment has been associated with reduced arterial pressure. This pilot study tested the hypothesis that correcting mal-alignment of the Atlas vertebra reduces and maintains a lower BP. Using a double blind, placebo-controlled design at a single-center, 50 drug naïve (n = 26) or washed out (n = 24) patients with Stage 1 hypertension were randomized to receive a National Upper Cervical Chiropractic (NUCCA) procedure or a sham procedure. Patients received no anti-hypertensive meds during the 8-week study duration. The primary end-point was changed in systolic and diastolic BP comparing baseline and week 8, with a 90 % power to detect an 8/5 mm Hg difference at week 8 over the placebo group. The study cohort had a mean age 52.7 +/- 9.6 years, consisted of 70 % men. At week 8, there were differences in systolic BP (-17 +/- 9 mm Hg, NUCCA versus -3 +/- 11 mm Hg, placebo; p < 0.0001) and diastolic BP (-10 +/- 11 mm Hg, NUCCA versus -2 +/- 7 mm Hg; p = 0.002). Lateral displacement of Atlas vertebra (1.0, baseline versus 0.04 degrees week 8, NUCCA versus 0.6, baseline versus 0.5 degrees , placebo; p = 0.002). Heart rate was not reduced in the NUCCA group (-0.3 beats/min, NUCCA, versus 0.5 beats/min, placebo). No adverse effects (AEs) were recorded. The authors concluded that restoration of Atlas alignment was associated with marked and sustained reductions in BP similar to the use of 2-drug combination therapy.

The authors stated that this pilot study had limitations including the fact that it was dependent on the skill of one practitioner to do the manipulation. It was designed, however, to test the concept that non-surgical manipulation could alleviate elevations in BP, thus it could not be generalized until confirmed in a larger trial, which is being planned.

Westersund et al (2017) stated that clinical observation and anecdotal reports suggested changes could occur to dental occlusion following intervention with the NUCCA procedure. This case-controlled study discerned if occlusion changes are measurable using a dental force plate (T-Scan) following an adjustment to the cranio-cervical junction (CCJ). A degree of case control was established by active patients being assessed twice prior to and following intervention. Before-after intervention assessment included posture evaluation and dental occlusion (T-Scan). Findings suggested that changes in posture and occlusion could be observed after the NUCCA chiropractic procedure. Not all patients demonstrated a more balanced contact pattern following the adjustment, indicating a need for further investigation. The authors concluded that these findings may suggest interconnectivity between the CCJ and an individual's occlusal contacts and support the need for further integration between chiropractors and dentists seeking to co-manage temporo-mandibular joint (TMJ) disorders.

Furthermore, the Washington State Chiropractic Commission (2014) did not endorse the National Upper Cervical Chiropractic Association (NUCCA) procedure as an adjustive technique.

Improvement of Brain Function

Meyer and colleagues (2019) noted that a recent hypothesis purports that spinal manipulation may cause changes at a brain level. Functional neurology, a mainly chiropractic approach, promotes the use of spinal manipulation to improve "brain function" as if it were a proven construct. No systematic review has been performed to investigate how well founded this hypothesis is. In this systematic review, these researchers examined if spinal manipulation has an effect on "brain function" that is associated with any clinical benefits. They carried out a literature searched in PubMed, Embase, and PEDro (final search in February 2018). These investigators included RCTs or non-RCTs, in which spinal manipulation was performed to any region of the spine, applied on either symptomatic or asymptomatic individuals, and compared to a sham or to another type of control. The outcome measures had to be stated as direct or proxy markers of "brain function". Studies were reviewed blindly by at least 2 reviewers, using a quality check-list designed for the specific needs of the review. Studies were classified as of "acceptable", "medium", or '"ow" methodological quality. Results were reported in relation to control intervention (sham, "inactive control", or "another physical stimulus"); and study subjects (healthy, symptomatic, or with spinal pain "subjects/spinal pain"), taking into account the quality. Only results obtained from between-group or between-intervention comparisons were considered in the final analysis. A total of 18 of 1,514 articles were included. Studies were generally of "low" or "medium" methodological quality, most comparing spinal manipulation to a control other than a sham; 13 out of the 18 studies could be included in the final analysis. Transitory effects of different types of "brain function" were reported in the 3 studies comparing spinal manipulation to sham (but of uncertain credibility), in "sub-clinical neck/spinal pain" subjects or in symptomatic subjects. None of these 3 studies, of "medium" or "acceptable" quality, examined if the neurophysiological effects reported were associated with clinical benefits. The remaining 10 studies, generally of "low" or "medium" quality, compared spinal manipulation to "inactive control" or "another physical stimulus" and similarly reported significant between-group differences but inconsistently. The authors concluded that the available evidence suggested that changes occurred in "brain function" in response to spinal manipulation but were inconsistent across and sometimes within studies. These researchers stated that the clinical relevance of these changes is unknown; thus, It is premature to promote the use of spinal manipulation as a treatment to improve "brain function".

Rheumatic Diseases

In a systematic review, Phang and colleagues (2018) summarized all good quality RCTs using CAM interventions in patients with rheumatic diseases. These researchers carried out a literature review guided by the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA). They excluded non-English language articles and abstract-only publications. Due to the large number of RCTs identified, these investigators only included "good quality" RCTs with Jadad score of 5. They identified 60 good quality RCTs using CAM as intervention for patients with rheumatic diseases: acupuncture (n = 9), Ayurvedic treatment (n = 3), homeopathic treatment (n = 3), electricity (n = 2), natural products (n = 31), mega-vitamin therapies (n = 8), chiropractic or osteopathic manipulation (n = 3), and energy healing therapy (n = 1). The studies did not appear to suggest a particular type of CAM was effective for all types for rheumatic diseases. However, some CAM interventions appeared to be more effective for certain types of rheumatic diseases. Acupuncture appeared to be beneficial for osteoarthritis (OA), but not rheumatoid arthritis (RA). For the other therapeutic modalities, the evidence base either contained too few trials or contains trials with contradictory findings that precluded any definitive summary. There were only minor adverse reactions observed for CAM interventions presented. The authors identified 60 good quality RCTs that were heterogenous in terms of interventions, disease, measures used to evaluate outcomes, and efficacy of CAM interventions. Evidence indicated that some CAM therapies may be useful for rheumatic diseases, such as acupuncture for OA. These researchers stated that further research with larger sample size is needed for more conclusive evidence regarding the efficacy of CAM interventions for the management of patients with rheumatic diseases.

Chiropractic BioPhysics Methods for the Treatment of Lumbar Lordosis and/or Low Back Disorders

In a systematic review, Oakley and colleagues (2020) examined controlled trial evidence for the use of lumbar extension traction by Chiropractic BioPhysics methods for increasing lumbar lordosis in those with hypo-lordosis and low back disorders. These investigators carried out literature searches in PubMed, PEDro, CINAHL, Cochrane, and ICL data-bases. Search terms included iterations related to the lumbar spine, LBP and extension traction rehabilitation. A total of 4 articles detailing 2 randomized and 1 non-randomized trial were located. Trials demonstrated increases in radiographic measured lordosis of 7 to 11°, over 10 to 12 weeks, after 30 to 36 treatment sessions. Randomized trials demonstrated traction treated groups mostly maintained lordosis correction, pain relief, and disability after 6-months follow-up. The non-randomized trial showed lordosis and pain intensity were maintained with periodic maintenance care for 1.5 years. More importantly, control/comparison groups had no increase in lumbar lordosis. Randomized trials showed comparison groups receiving physiotherapy-less the traction, had temporary pain reduction during treatment that regressed towards baseline levels as early as 3 months after treatment. The authors concluded that limited but good quality evidence substantiated that the use of extension traction methods in rehabilitation programs definitively increased lumbar hypo-lordosis. Moreover, these researchers stated that preliminarily, these studies showed these methods provide longer-term relief to patients with low back disorders versus conventional rehabilitation approaches tested. They stated that future studies testing lumbar extension traction methods are needed for a more adequate understanding of this new important treatment procedure, including but not limited to older and younger patient populations.

The authors stated that due to the limited number of studies, the conclusions from this review are preliminarily. Another drawback was that the measurement method for lumbar lordosis across the studies had slight variation (e.g., L1 to L5 absolute rotation angle [ARA]) versus L1 to L5 Cobb angle versus T12 to S1 ARA; despite this, the significant improvements in lumbar extension traction treatment groups were reported within each trial. In addition, the population groups studied were all similar, mid-aged adults (average ages of 39 to 46 years). Although limited, there was good quality evidence that indicated increasing the lumbar lordosis via extension traction as part of multi-modal rehabilitation programs were associated with superior outcomes over "standard-care" treatment programs that did not improve hypo-lordosis. These researchers stated that future studies are needed to overcome the limitations identified and improve the understanding of lumbar extension traction methods discussed in this review. For example, a study seeking to identify the optimum subgroup of patient lumbar curvatures that will respond to lumbar extension traction as they relate to initial pelvic morphology values is needed. Second, a study examining multiple programs of lumbar extension traction applications is needed; in this way the optimum dose response over time can be identified for those patients who improve but still remain with pain, disability, and loss of curvature. Third, an RCT with a cross-over design is needed in order to more accurately identify that patients receiving lumbar extension traction applications for lumbar hypo-lordosis are the ones who indeed have the optimum improvement for their back pain and related disabilities.

Chiropractic Care for the Treatment of Postpartum-Related Low-Back Pain, and/or Pelvic Girdle Pain

In a systematic review, Weis and colleagues (2020) (SR) examined the effectiveness of specific chiropractic care options commonly used for postpartum-related LBP, PGP, or combination (LBP and PGP) pain. Interventions were those manual or other non-pharmacologic therapies commonly used by chiropractors (not requiring additional certifications). The outcomes were self-reported changes in pain or disability self-reported outcomes. These investigators used the Scottish Intercollegiate Guideline Network check-lists. Strength of the evidence (excluding cohort studies) was determined using an adapted version of the U.S. Preventive Services Task Force criteria as described in the U.K. report. Of the 1,611 published articles, 16 were included. These were 5 systematic reviews, 10 RCTs, and 1 cohort study. Postpartum-related LBP (1 RCT): moderate, favorable strength for spinal manipulation therapy/mobilization. Postpartum-related PGP (4 RCTs): moderate, unclear strength for exercise; and inconclusive, unclear strength for patient education. Postpartum-related LBP or PGP (3 systematic reviews and 4 RCTs): inconclusive, unclear strength for exercise, self-management, and physiotherapy; while osteopathic manipulative therapy was inconclusive, favorable. The authors concluded that no therapeutic option was identified as having sufficient evidence to make a clear recommendation. This systematic review identified a scarcity of literature regarding chiropractic care and back pain for postpartum women, as well as inconsistency among the terms LBP, PGP, and combination pain. These researchers stated that the findings of this systematic review demonstrated the need for higher-quality and more robust studies in this population.

Combined Chiropractic and Acupuncture for the Treatment of Cervical Spondylosis Radiculopathy

Wang and colleagues (2020) stated that the pathogenesis of cervical spondylosis is degenerative changes of the cervical intervertebral disc, or bone hyperplasia of the posterior and hook joints, and instability of the joints of the cervical vertebrae. It causes the nerve roots to be stimulated and oppressed. The clinical manifestations are the sensation, movement, and reflex disorder of the cervical spinal nerve roots that are stimulated and oppressed, especially numbness and pain of the neck, shoulders, and upper extremities. In a systematic review, these investigators aimed to examine the safety and efficacy of combined chiropractic and acupuncture in the treatment of cervical spondylosis radiculopathy. They will search for PubMed, Cochrane Library, AMED, Embase, WorldSciNet, Nature, Science online and China Journal Full-text Database (CNKI), China Biomedical Literature CD-ROM Database (CBM), and related RCTs included in the China Resources Database. The time is limited from the construction of the library to September 2019. These researchers will use the criteria provided by Cochrane 5.1.0 for quality assessment and risk assessment of the included studies, and use the RevMan 5.3 and Stata 13.0 software for meta-analysis of the effectiveness, recurrence rate, and symptom scores of cervical spondylosis radiculopathy. The authors noted that this systematic review will examine the safety and efficacy of combined chiropractic and acupuncture for the treatment of cervical spondylosis radiculopathy. They stated that the results of this study may provide a possible ranking for acupuncture and chiropractic treatment of cervical spondylosis radiculopathy.

Chiropractic for the Management of Axial Spondyloarthritis

Deodhar and colleagues (2022) noted that diagnosis of axial spondyloarthritis (axSpA) is often associated with chronic inflammatory back pain (IBP) and frequently occurs years after initial onset of clinical symptoms. Recognition of IBP is important for timely referral of patients with suspected axSpA to a rheumatologist. Patients with all types of back pain are treated in chiropractic care; however, the proportion of patients with undiagnosed axSpA is unknown. In a systematic review, these investigators examined the presence of axSpA in patients treated by chiropractors and identified the chiropractor's role in axSpA diagnosis, referral, and management. They carried out a PubMed search using the following search strings: "chiropract*" AND ("sacroiliac" OR "back pain" OR "spondyloarthritis" OR "ankylosing spondylitis"); English language, since 2009; and (chiropractic OR chiropractor) AND (ankylosing spondylitis OR axial spondyloarthritis), with no date limits. Of 652 articles identified in the searches, 27 met the inclusion criteria. Although back pain was identified as a common reason for patients seeking chiropractic care, there was no mention of axSpA, ankylosing spondylitis, or the distinction between mechanical and IBP. Data from relevant articles suggested that the majority of patients seeking chiropractic care have LBP, whereas no articles reported axSpA in this patient population. The authors concluded that the near absence of any identified articles on axSpA in chiropractic care may be due to under-recognition of axSpA, resulting in delayed rheumatology referral and appropriate management. They stated that better awareness and increased use of validated screening tools could reduce diagnostic delay of axSpA in chiropractic care.

Furthermore, an UpToDate review on “Treatment of axial spondyloarthritis (ankylosing spondylitis and nonradiographic axial spondyloarthritis) in adults” Yu and van Tubergen, 2021) states that “Spinal manipulation should be avoided in patients with spinal fusion or advanced spinal osteoporosis”.

Chiropractic Biophysics Technique / Chiropractic BioPhysics Methods

In a single-case report, Kallan et al (2022) showed the reduction of lumbar hyper-lordosis, sacral base angle and anterior thoracic translation posture in an 11-year-old girl. Subject presented with lumbar hyper-lordosis and underwent CBP treatment protocols to reduce her spinal deformity and correlated symptoms. Symptoms included thoracolumbar, hip, knee and ankle pains and lower extremity weakness. Radiographs confirmed lumbar hyper-lordosis, increased sacral base angle and a forward translated thoracic posture. Spinal traction as well as corrective exercises and spinal manipulative therapy was carried out over an 11-month period. After 57 treatments, there was a 13.4° reduction in L1 to L5 lordosis, an 11.8° reduction in sacral base angle and a 13.8 mm reduction in anterior thoracic translation. The improved structural changes correlated with improved symptoms. The authors concluded that lumbar hyper-lordosis could be reduced in pediatric patients presenting with hyper-lordosis and associated symptomatology. Routine radiography may be needed in the diagnosis of lumbar spine deformities in pediatrics. Moreover, these investigators stated that further research into the non-surgical reduction of lumbar spine hyper-lordosis is needed.

The authors stated that main drawback of this study was that it was a single-case study. The similarity of structural correction in this case as compared to the few other reports documenting non-surgical reduction in lumbar hyper-lordosis showed promise that CBP methods employed to reduce lumbar hyper-lordosis may be equally effective in adults and children. In fact, one issue that needs to be unveiled is what standard treatment protocol needs to be adopted for children versus adults in the application of CBP methods considering their unique differences (i.e., flexibility, etc.). These investigators stated that further research is needed for all age groups.

Chiropractic Manipulation for the Prevention of Fall

Grabowska et al (2022) stated that falls in the elderly are a significant and growing public health concern. There are multiple risk factors associated with falls that may be addressed within the scope of chiropractic training and licensure. Few attempts have been made to summarize existing evidence on multi-modal chiropractic care and fall risk mitigation. In a systematic review , these investigators summarized this research to-date. They carried out a systematic review according to the PRISMA guidelines. Databases searched included PubMed, Embase, Cochrane Library, PEDro, and Index of Chiropractic Literature. Eligible study designs included RCTs, prospective non-randomized controlled, observational, and cross-over studies in which multi-modal chiropractic care was the primary intervention and changes in gait, balance and/or falls were outcomes. Risk of bias was also evaluated using the 8-item Cochrane Collaboration Tool. The original search yielded 889 articles; 21 met final eligibility including 10 RCTs. One study directly measured the frequency of falls (under-powered secondary outcome) while most studies examined short-term measurements of gait and balance. The overall methodological quality of identified studies and findings were mixed, limiting interpretation regarding the potential impact of chiropractic care on fall risk to qualitative synthesis. The authors concluded that little high-quality research has been published to inform how multi-modal chiropractic care could best address and positively influence fall prevention. These researchers proposed strategies for building an evidence base to examine the role of multi-modal chiropractic care in fall prevention and outline recommendations for future research to fill current evidence gaps. Moreover, these investigators stated that future research on falls and mobility represents both an exciting area of contribution for the chiropractic profession and a critical topic for public health.

The authors stated that this study had several drawbacks. First, only studies in the English language were included, the search strategy was developed without formal help from a librarian, and a protocol was not developed or registered a priori. Second, based on the limited evidence to-date, only a small number of studies met the inclusion and exclusion criteria. Third, there was a great deal of heterogeneity across the included studies in terms of study design characteristics, methodologic quality, demographics of subjects, interventions, outcomes, and settings, excluding the possibility of quantitative synthesis with meta-analysis, and significantly constraining narrative synthesis. Of note, the majority of included studies were small pilot studies, with overall low methodological quality. As a whole, this heterogeneity and low methodological quality limited the conclusions that can be drawn from these data. Fourth, the inclusion criteria targeted studies that included evaluations of components of multi-modal chiropractic care (e.g., spinal manipulation, and myofascial therapies), as delivered by a doctor of chiropractic (DC). Some of these modalities were also delivered by other professions (e.g., osteopath, physical therapist), and because of the limits of the search strategy, these findings could not distinguish chiropractic-specific impacts of the included interventions compared to the impacts of these interventions as delivered by other professions.

Chiropractic Manipulation for the Treatment of Post-Concussion Syndrome

Masarsky (2018) noted that hypopituitarism diagnosed months or years following concussive injury can cause a variety of endocrine disturbances including insufficient secretion of human growth, luteinizing, follicle stimulating, thyroid stimulating, adrenocorticotrophic, and anti-diuretic hormones (GH, LH, FSH, TSH, ACTH, and ADH). Recent evidence suggested that autoimmune reactions against pituitary and/or hypothalamic tissue constitute an etiologic factor for this hypopituitarism. One important trigger for autoimmunity is hypoxic stress. This trigger may be especially important in the post-concussive brain, which is particularly vulnerable to hypoxic stress. The vulnerable vasculature of the hypothalamic infundibulum can be a source of local exacerbation of any systemic hypoxia. Taking the above into account, it appeared reasonable to hypothesize that hypoxic stress is a risk factor for post-concussive hypopituitarism. Following a discussion of literature relevant to this hypothesis, these researchers suggested retrospective and prospective research methods for testing the hypothesis. Retrospective methods for hypothesis testing include comparing post-concussion victims with and without evidence of hypopituitarism in terms of their history of respiratory problems such as smoking, exposure to indoor and outdoor air pollution, chronic obstructive pulmonary disease (COPD), asthma, obstructive sleep apnea (OSA), and opioid use or abuse. Significantly greater incidence of respiratory history among the hypopituitarism patients would support the hypothesis. Prospective methods include performing detailed respiratory history and examination immediately post-injury, then performing periodic endocrine panels to detect hypopituitarism during long-term follow-up. The hypothesis will be supported if development of hypopituitarism among patients with positive respiratory history or examination findings post-injury is more frequent than hypopituitarism among concussion victims with negative respiratory history and examination findings. If the hypothesis is supported, effective prevention of post-concussive hypopituitarism should include efforts to support optimal respiratory function. Such efforts may be relevant to treatment as well. These efforts would include respiratory therapy, smoking cessation, treatment of OSA, prudent stepping down of opioid use, incentive spirometry, aerobic exercise, and other conventional measures as indicated. Non-Western measures such as yoga should be considered as well. Furthermore, chiropractic care as an intervention that may ameliorate hypoxia at the systemic and local levels was discussed. These researchers stated that it is worth mentioning the literature that suggested chiropractic adjustments could alleviate reflex sympathetic dystrophy. While these cases did not involve the pituitary as such, the normalization of vasomotor tone suggested that chiropractic adjustments may also alleviate vasoconstriction at the infundibular choke point of the hypothalamus. This would tend to alleviate hypoxic stress at the local tissue level. Taking all of the above into account, if the hypoxic stress hypothesis of post-concussive hypopituitarism is supported, the objective of prevention would best be served by an integrative health care approach including chiropractic and all other relevant practices. Such an approach has recently been advocated by Cohen et al in relation to care of the cardiovascular patient. This study did not provide any clinical data regarding the effectiveness of chiropractic for the treatment of post-concussion syndrome (PCS).

In a case-series study, Germann et al (2020) described the multi-modal treatment plans delivered by 2 chiropractic sports specialists for the management of PCS. A total of 3 concussion cases were presented each with different mechanisms of injury (2 sport-related and 1 non-sport-related) and each within a different stage of recovery (acute, sub-acute, and chronic). Treatment plans included patient education, sub-symptom threshold exercise, soft-tissue therapy, spinal manipulation, and cervical spine as well as visual/vestibular rehabilitation exercises. This series highlighted 3 important observations: First, the effectiveness of individualized, multi-modal treatment plans based on suggested clinical profiles for patients with PCS of various stages. Second, the delineation of concussion literature based on mechanism of injury (i.e., sport- versus non-sport-related) may be unnecessary. Third, these cases provided encouraging evidence to support the inclusion of manual therapists with advanced knowledge of concussion treatment, such as chiropractors, as part of the inter-disciplinary healthcare team when managing patients with PCS. The authors concluded that emerging research suggested that patients diagnosed with PCS, regardless of the mechanism of injury, can be characterized by 1 or more clinical profiles based on their clinical assessment. These clinical profiles can then guide the development of individualized, multi-modal treatment plans that can significantly improve patients’ symptoms. There is limited evidence describing the role that chiropractic sport specialists may play in the inter-disciplinary management of concussion outside of sport. This case series described 3 individualized multi-modal treatment plans delivered by sports chiropractors that included sub-symptomatic threshold exercise, vestibulo-ocular rehabilitation, spinal manipulation, soft-tissue therapy, and dietary modification during the management of both sport and non-sport related concussion. The positive results from this case series further contribute to the evolving literature supporting the role of chiropractors in the primary management of concussive symptoms of various origin and duration.

The authors stated that this case series had several drawbacks. First, the absence of original diagnostic imaging and laboratory reports for Case 3. During this time the patient relocated and changed family physicians and was not able to obtain copies of these investigations. These diagnostic reports would aid in describing the breadth of evaluations the patient in Case 3 had undergone and would emphasize the difficulty experienced in previous attempts at managing this case. Second, results from a baseline post-concussion-symptom scale (PCSS) score in Cases 1 and 3, and a final follow-up PCSS score in Case 2 would provide reference upon which one could better judge the extent of the patients’ recovery. Although the patient in Case 3 reported the continuation of 3 low-level symptoms at the point of discharge, it has been noted that both healthy controls and those with other co-morbidities reported the presence of various non-specific symptoms that are also commonly experienced by those with PCS. Thus, one was unable to determine whether or not the patient would have reported these symptoms on a baseline PCSS even before her injury. Such a situation was well demonstrated by the baseline PCSS results of the patient in Case 2. Third, the use of a multi-modal treatment plan created a challenge when trying to determine which intervention is providing therapeutic benefit to the patient. Fourth, although the recovery outcomes were positive in each of the 3 cases in this series, it should be noted that there were inherent limitations in the generalizability of case series results to other concussed patients. Fifth, the concept of “clinical profiles / domains” is still an emerging theory, and it is uncertain at what time during recovery these clinical profiles become important with respect to treatment outcomes. These researchers stated that additional research on the use of impairment-based, multi-modal treatment plans, along with the timing for which such a plan should be implemented is needed.

Rytter et al (2021) stated that persistent (greater than 4 weeks) post-concussion symptoms (PPCS) are challenging for both patients and clinicians. There is uncertainty regarding the effect of commonly applied non-pharmacological treatments for the management of PPCS. These investigators systematically examined evidence for outcomes related to 7 non-pharmacological interventions for PPCS in adults (aged greater than 18 years) and provided recommendations for clinical practice. They carried out a systematic literature searches via Embase, Medline, PsycINFO, CINAHL, PEDro, OTseeker, and Cochrane Reviews (via Medline and Embase) from earliest possible publication year to March 3, 2020. The literature was searched for prior systematic reviews and primary studies. To be included, studies had to be intervention studies with a control group and focus on PPCS. A multi-disciplinary guideline panel selected interventions based on frequency of use and need for decision support among clinicians, including early information and advice, graded physical exercise, vestibular rehabilitation, manual treatment of neck and back, oculomotor vision treatment, psychological treatment, and inter-disciplinary coordinated rehabilitative treatment. To be included, studies had to be intervention studies within the areas of the predefined clinical questions, include a control group, and focus on symptoms after concussion or mild traumatic brain injury (TBI). Extraction was carried out independently by multiple observers. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for data abstraction and data quality assessment. Included studies were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) tool and the Cochrane Risk of Bias (randomized clinical trials) tool. Meta-analysis was performed for all interventions where possible. Random-effects models were used to calculate pooled estimates of effects. The level and certainty of evidence were rated; and recommendations formulated according to the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework. All outcomes were planned before data collection began according to a specified protocol. The primary outcomes were the collective burden of PPCS and another outcome reflecting the focus of a particular intervention (e.g., physical functioning after graded exercise intervention). A total of 11 systematic reviews were identified but did not contribute any primary studies; 19 randomized clinical trials comprising 2,007 participants (1,064 women [53.0 %]) were separately identified and included. Evidence for the 7 interventions ranged from no evidence meeting the inclusion criteria to very low and low levels of evidence. Recommendations were weak for early information and advice, graded physical exercise, vestibular rehabilitation, manual treatment of the neck and back, psychological treatment, and inter-disciplinary coordinated rehabilitative treatment. No relevant evidence was identified for oculomotor vision treatment, so the panel provided a good clinical practice recommendation based on consensus. The authors concluded that based on very low to low certainty of evidence or based on consensus, the guideline panel found weak scientific support for commonly applied non-pharmacological interventions to treat PPCS. Results align with recommendations in international guidelines. Intensified research into all types of intervention for PPCS is needed. Chiropractic is not mentioned as a therapeutic / management option for the treatment of PPCS.

Furthermore, an UpToDate review on “Postconcussion syndrome” (Evans, 2022) does not mention chiropractic as a management / therapeutic option.

Ultralign Adjusting Device

The SIGMA Instrument (also known as Ultralign, ProAdjuster) is a computer-based, chiropractic adjusting instrument that gently percusses the tissue area being tested, giving the practitioner vital information regarding the motion dynamics and the resonant frequency of the spinal joint or surrounding soft tissue. The SIGMA instrument measures the stiffness of the tissue or joint by applying a light mechanical force in the form of a percussion wave and oscillating frequency; a signal is then reflected back to the instrument, which then measures the spine and tissue response, sending it to the computer for interpretation, all before the muscle can respond. The process occurs so fast that it reduces the normal defense mechanism or guarding response, caused by typical palpation.

References

The above policy is based on the following references:

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Last Review 03/23/2023

Effective: 03/25/1995

Next Review: 01/25/2024
Review History
Definitions

Chiropractic Services

Table Of Contents

Policy

Scope of Policy

Medical Necessity

Experimental and Investigational

Manipulation when it is rendered for non-neuromusculoskeletal conditions (see examples below, not an all-inclusive list):

Manipulation of infants for non-neuromusculoskeletal indications (see examples below, not an all-inclusive list):

Chiropractic procedures:

Diagnostic procedures:

Policy Limitations and Exclusions

Related Policies

CPT Codes / HCPCS Codes / ICD-10 Codes

CPT codes covered if selection criteria are met:

CPT codes not covered for indications listed in the CPB:

ConnecTX, inertial traction, positional release therapy, IntraDiscNutrosis program, Origin insertion release technique, Ultralign adjusting device - no specific code:

Other CPT codes related to the CPB:

HCPCS codes covered if selection criteria are met:

Other HCPCS codes related to the CPB:

ICD-10 codes covered if selection criteria are met (0-3 years of age):

ICD-10 codes covered if selection criteria are met for adults and children (4 years of age and older):

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):