Inclusion criteria | Rationale |
Neck or neck-related upper limb pain consistent with Quebec Task Force classifications 2 to 4 | Neck pain radiating to proximal or distal extremity with or without neurological signs is commonly treated by doctors of chiropractic using study procedures |
Naïve to flexion-distraction manual therapy procedures to cervical area | Requires participant unfamiliarity with study interventions |
Exclusion criteria | Rationale |
Neck pain consistent with Quebec Task Force classifications 1, 5 to 11 | Classifications represent diagnoses that may require individualized treatment not available in trial; condition(s) may limit interpretation of study measurements |
Bone/joint pathologies representing a contraindication to study procedures, including but not limited to: | Â |
1) Inflammatory arthritis involving the cervical spine: i.e., rheumatoid arthritis, systemic lupus erythematosus, etc. | Study prescribed treatments are not intended for these conditions; may require referral and interfere with data collection and interpretation |
2) Any condition representing neurological (spinal) instability in cervico-thoracic spine | Condition requires referral for evaluation or care outside study scope |
3) Tumors, within or adjacent to the cervico-thoracic spinal canal | Condition requires evaluation or care outside study scope |
4) Arnold Chiari malformation | May represent condition requiring referral for evaluation or care and limit interpretation of study measurements |
5) Disorders known to exhibit spinal joint hypermobility, such as: Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta | May represent condition requiring referral; may interfere with data collection and interpretation |
6) Cervico-thoracic disc herniation or prolapse demonstrating advancing neurologic deficits | Condition requires referral for evaluation or care outside study scope |
7) Sequestered intervertebral disc fragment or loose bodies within the spinal canal, lateral recess, or intervertebral foramen | Safety precaution for available treatment protocols and may require referral |
8) Any condition not listed above representing a contraindication to or a safety risk for study procedures | Safety precaution for treatment or biomechanical testing protocols and may require referral |
Any single or multisegmental fusion (surgical or congenital) of the first through the seventh cervical vertebrae | Intervention hypothesizes that joint distraction and intervertebral disc pressure change are principal therapeutic mechanisms |
Safety precaution (e.g., inability to safely ambulate within clinic, dizziness when arising or lying on treatment table, anxiety from study procedures) | Safety precaution and may interfere with participant’s ability to comply with study protocol |
Unable to tolerate study procedures | Safety precaution for treatment or biomechanical testing procedures |
Simultaneous management for condition compromising ability to deliver study treatment or assess health status | Safety precaution for treatment protocols and may present an undue scheduling burden |
Suspicion of alcohol or drug abuse | May interfere with data collection, ability to comply with study protocol, and requires referral |
Cognitive or memory impairment | May prohibit informed consent or compromise safety due to potentially reduced comprehension or compliance with study procedures |
Referral for evaluation/management of other condition(s) or further testing required for neck pain diagnosis | Safety precaution and extensive or advanced diagnostic testing outside study scope |
Compliance concerns* | May compromise ability to adhere to study protocol |