Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01765751
Eligibility Criteria:
Inclusion Criteria
* Age 18 to 70 years (inclusive).
* Mechanical neck pain or neck-related upper extremity pain lasting at least 4 weeks duration.
* Mechanical neck pain or neck-related upper extremity pain classified as Quebec Task Force (QTF) 2-4.
* Naïve to flexion-distraction manual therapy procedures to cervical area.
* Average neck pain in the past 24 hours rated between 3 and 7 on a 0-10 Pain Numerical Rating Scale (NRS) at Phone Screen and Baseline 1 Interview.
* Signed Informed Consent Document.
Exclusion Criteria
* Doctor of chiropractic or current or former chiropractic student.
* Average neck pain in past 24 hours rated 0-2 or 8-10 on a 0-10 Pain NRS at Phone Screen and Baseline 1 Interview.
* Neck pain from other than somatic tissues as determined by history and clinical examination.
* Surgery to cervical-thoracic area within the past 6 months.
* Recent fracture in the cervico-thoracic spine or ribs within the past 8 weeks.
* Injections for pain in neck, shoulders, arms or hands in the past 4 weeks.
* Neck pain classified as QTF 1, 5-11.
* Unwillingness to postpone use of all types of manual treatment for neck pain, except those provided in the study for the duration of the study.
* Inability or unwillingness to comply with study protocols.
* Bone or joint pathologies representing a contraindication to study procedures.
* Any single or multisegmental fusion (surgical or congenital) of the 1st through the 7th cervical vertebrae.
* Other safety concerns as determined by the clinical evaluation/opinion at case review.
* Unable to tolerate study procedures.
* Uncontrolled hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
* Simultaneous clinical management for a health condition that compromises ability to deliver study treatment or assess health status.
* Inability to read or verbally comprehend English.
* Drug or alcohol abuse or dependence, suspected or confirmed through self-report questionnaires and clinical interview.
* Depression rated as ≥ 29 on the Beck Depression Inventory.
* Cognitive or memory impairment identified during eligibility exam.
* Pregnancy, under either of the following 2 circumstances: 1) Participant safety, if participant is unable to tolerate or undergo study procedures; or 2) Fetus safety, if x-rays are required for diagnosis.
* Weight greater than 300 lbs (table weight limit).
* Referral for evaluation, diagnosis, or management of other health conditions, or additional diagnostics required for neck pain diagnosis.
* Retention of legal advice or seeking a health-related insurance claim.
* Household member previously enrolled in MCD Clinical Trial.
* Compliance concerns identified during baseline eligibility process.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01765751
Study Brief:
Protocol Section:
NCT01765751