Table 1 Eligibility criteria
Inclusion criteria | Rationale |
|---|---|
Neck or neck-related upper limb pain consistent with Quebec Task Force (QTF) classifications 2-4 [75] | Study intervention was designed to treat radiating neck pain (proximal or distal extremity) with or without neurological signs |
Naïve to manual cervical distraction procedures to cervical spine region | Treatment credibility assessment requires unfamiliarity with study interventions |
Exclusion criteria | Rationale |
Neck pain without radiation (QTF classification 1) [75] | Intervention designed to treat radiating neck pain |
Presumptive compression of a nerve root on roentgenogram (i.e, instability fracture) (QTF classification 5) | May require individualized treatment not available in trial |
Compression of spinal nerve root confirmed with imaging (QTF classification 6) | May require individualized treatment not available in trial; condition may limit interpretation of study measurements |
Spinal stenosis (QTF classification 7) | May require individualized treatment not available in trial; condition may limit interpretation of study measurements |
Postsurgical status <6Â months (QTF classification 8) | May require individualized treatment not available in trial; condition may limit interpretation of study measurements |
Postsurgical status >6Â months (QTF classification 9) | May require individualized treatment not available in trial; condition may limit interpretation of study measurements |
Chronic pain syndrome (QTF classification 10) | Care needed is outside study scope |
Other diagnoses from visceral disease, metastasis, etc. (QTF classification 11) | Care needed is outside study scope |
Inflammatory arthritis in the cervical spine: i.e., rheumatoid arthritis, systemic lupus erythematosus | Study treatments are not intended for these conditions |
Neurological (spinal) instability in cervico-thoracic spine | Treatment needed is outside study scope |
Tumors, within or adjacent to the cervico-thoracic spinal canal | Treatment needed is outside study scope |
Arnold Chiari malformation | May require referral, additional evaluation or treatment outside study scope |
Spinal joint hypermobility, such as: Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta | May interfere with data collection and interpretation |
Advancing neurologic deficits | Treatment needed is outside study scope |
Sequestered intervertebral disc or loose body within the cervical spinal canal, lateral recess, or intervertebral foramen | Safety precaution |
Fusion (single or multisegmental) of the cervical vertebrae | Joint distraction and intervertebral disc pressure change are hypothesized as principal therapeutic mechanisms |
Safety precaution (e.g., unable to ambulate within clinic, dizziness, weight beyond treatment table limits [300 lbs]) | Safety precaution |
Unable to tolerate study procedures | Safety precaution |
Simultaneous management for a condition compromising ability to deliver study treatment or assess health status | Safety precaution 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 neck pain diagnosis | Safety precaution and advanced diagnostic testing outside study scope |
Compliance concerns | Transportation issues, scheduling conflicts, etc. may compromise adherence to study protocol |