Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial

Completed · Not applicable

Conditions studied: Neck Pain, Pain in Arm, Unspecified

In brief

The purpose of the Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial is to examine the patient-centered clinical and biomechanical outcomes, doctor treatment delivery, and believability characteristics of a commonly used chiropractic procedure for the treatment of neck- or neck-related arm pain or disability.

Key facts

Study ID

NCT01765751

Run by

Palmer College of Chiropractic

People needed

48

Starts

2013-01-01

Expected to finish

2013-10-01

Last updated by the study team

2018-01-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Palmer Center for Chiropractic Research — Davenport, Iowa, United States

Full record on ClinicalTrials.gov

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