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Table 1 Eligibility criteria

From: Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain

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 <6 months (QTF classification 8) May require individualized treatment not available in trial; condition may limit interpretation of study measurements
Postsurgical status >6 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