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

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of the Manual Cervical Distraction (MCD): Measuring Chiropractic Delivery for Neck Pain Clinical Trial is to examine the patient-centered clinical and biomechanical outcomes, and believability characteristics of a manually-localized cervical distraction procedure for the treatment of neck- or neck-related arm pain or disability. One challenging issue in the study of manual therapies, including spinal manipulation (SM), is the development of sham and/or minimal intervention procedures suitable for use with control groups in clinical trials. With SM, active treatment requires substantial physical contact between a study clinician and the study participant, either directly or through a mechanical intermediary. Consequently, it is difficult to introduce differences in manual therapy procedures that distinguish sham and/or minimal interventions from the active treatment, but are not immediately obvious to the study participant. Another challenging issue is training clinicians to deliver a standardized SM treatment within specified force ranges. The muscles surrounding the neck could alter the forces transmitted to the cervical spine, and could alter the treatment effectiveness. The purpose of this pilot randomized controlled trial is to examine the patient-centered clinical, biomechanical, and believability outcome characteristics of a manually-localized cervical distraction procedure for the treatment of neck or neck-related arm pain or disability. We also will evaluate the ability of the doctor of chiropractic to deliver the MCD treatment within specified force ranges. An exploratory aim of this study is to evaluate EMG measurement during MCD delivery.

Official Title
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Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies

Conditions
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Neck Pain, Pain in Arm, Unspecified

Intervention / Treatment
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* Procedure: Manual Cervical Distraction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Cervical Distraction High Force<br>Manual Cervical Distraction forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. | Procedure: Manual Cervical Distraction<br>* Manual Cervical Distraction (MCD) is a form of Low Velocity Variable Amplitude Spinal Manipulation (LVVA-SM). MCD procedure is performed with participant lying prone on a load instrumented table with moveable headpiece allowing guided head movement while recumbent. Clinician gently grasps posterior aspect of participant's neck with a broad contact (contact hand) between thumb and index finger at specific vertebral level. With opposite hand, clinician grasps control handle. Using contact hand, clinician exhibits superior traction to maintain a contact at a single vertebral level and ensuring a gentle movement via contact with control handle. Goal is to create a slow rhythmic (1-3 sec) localized distractive movement. In this trial, only axial distraction (Cox protocol 1) will be used.<br>|
| Active Comparator: Manual Cervical Distraction Medium Force<br>Manual Cervical Distraction forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. | Procedure: Manual Cervical Distraction<br>* Manual Cervical Distraction (MCD) is a form of Low Velocity Variable Amplitude Spinal Manipulation (LVVA-SM). MCD procedure is performed with participant lying prone on a load instrumented table with moveable headpiece allowing guided head movement while recumbent. Clinician gently grasps posterior aspect of participant's neck with a broad contact (contact hand) between thumb and index finger at specific vertebral level. With opposite hand, clinician grasps control handle. Using contact hand, clinician exhibits superior traction to maintain a contact at a single vertebral level and ensuring a gentle movement via contact with control handle. Goal is to create a slow rhythmic (1-3 sec) localized distractive movement. In this trial, only axial distraction (Cox protocol 1) will be used.<br>|
| Sham Comparator: Manual Cervical Distraction Low Force<br>Manual Cervical Distraction forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. | Procedure: Manual Cervical Distraction<br>* Manual Cervical Distraction (MCD) is a form of Low Velocity Variable Amplitude Spinal Manipulation (LVVA-SM). MCD procedure is performed with participant lying prone on a load instrumented table with moveable headpiece allowing guided head movement while recumbent. Clinician gently grasps posterior aspect of participant's neck with a broad contact (contact hand) between thumb and index finger at specific vertebral level. With opposite hand, clinician grasps control handle. Using contact hand, clinician exhibits superior traction to maintain a contact at a single vertebral level and ensuring a gentle movement via contact with control handle. Goal is to create a slow rhythmic (1-3 sec) localized distractive movement. In this trial, only axial distraction (Cox protocol 1) will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Traction Forces | We will evaluate the clinician's ability to deliver three randomly assigned manual interventions to the cervical spine within specified traction force ranges (<20 Newtons [N], 20-50N, >50N). The primary outcome of this study is to determine the accuracy and consistency of traction force delivery ranges both between clinicians and within individual clinicians. Traction force ranges (C5 contact level and Occiput contact level) will be measured at each study visit (visits 1, 2, 3, 4, 5) for 2 weeks and averaged to calculate final outcome. | Day 1, 4, 8, 11, 14 (Each Study Visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | The NDI is a 10-item questionnaire modified from the Oswestry Low Back Pain Disability Index. The NDI has been shown to be a reliable and valid measure of disability due to neck pain, and responsive for measuring change. Study Visit 1 and Study Visit 5 Measures occur 2 weeks apart. The NDI scale is measured on a scale of 0-50, with 0 indicating no disability and 50 indicating complete disability. This measure is an adjusted mean NDI change. | Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5) | 
| Neck Pain Visual Analogue Scale (VAS) | The VAS has excellent metric properties, is easy to administer and score (0-100mm), and is commonly used in pain research. Our anchors will be no pain (score of 0) to worst pain imaginable (score of 100). We will ask participants to rate their current neck pain at baseline and pre-/post-treatment for all 5 study visits. This measure is adjusted mean neck pain VAS change. A single value was calculated by averaging. | Change from Baseline, Day 1, 4, 8, 11, 14 (Pre- and Post-Study Visits 1, 2, 3, 4, 5) | 
| Patient Reported Outcomes Measurement Information System (PROMIS-43) | The PROMIS-43 questionnaire will be used to measure general functional health status. PROMIS-43 questions measure physical function, anxiety, depression, fatigue, sleep disturbance, social role satisfaction, and pain interference and intensity. The table below displays the mean score at baseline. On the T-score metric & interpretation: A score of 40 is one SD lower than the mean of the reference population (REF POP). A score of 60 is one SD higher than the mean of the REF POP. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average REF POP. This could be a desirable or undesirable outcome, depending upon the concept being measured. For Physical Function and Satisfaction with Social Role, higher scores reflect a better outcome, while for the remaining concepts, higher scores reflect a worse outcome. PROMIS - Pain Interference adjusted for baseline neck pain VAS. | Change from Baseline to Day 14 (Study Visit 5) | 
| Cervical Range of Motion (cROM). | Cervical ranges of motion are a measure of functional status and can be used to assess dysfunction in the cervical spine. Baseline/visit 1 (BL) cROM is displayed for Flexion-Extension, Lateral Bending, and Rotation. The mean change in cROM from visit 1 to visit 5 (V5 change) is also displayed. | Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5) | 
| Procedure Believability Questionnaire | We will ask all participants whether they feel the study procedure would relieve their neck pain using the Procedure Believability Questionnaire. The response choices will be: Strongly believe the procedure will relieve my neck pain; Somewhat believe the procedure will relieve my neck pain; Somewhat believe the procedure will NOT relieve my neck pain; Strongly believe the procedure will NOT relieve my neck pain; and Don't know if the procedure will relieve my neck pain. A baseline (BL) evaluation will be completed based upon treatment description, and compared to assessments following study visit 1 (T1) and study visit 5 (T5) over a 2-week time period. | Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5) | 
| Credibility and Expectancy Questionnaire (CEQ) | The CEQ is a quick and easy-to-administer questionnaire for measuring treatment expectancy and rationale credibility of interventions for use in clinical outcome studies. Participants' perceptions of the study treatments were compared across groups using the CEQ. The CEQ credibility factor relates to how logical or believable a treatment is for the patient, whereas the expectancy factor refers to the patient's beliefs about improvements that might be achieved from the treatment [61]. CEQ scores for both the credibility and expectancy factors range from 3 to 27, with higher scores indicating greater belief in treatment credibility or expectancy for clinical improvement. | Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical pain, Neck pain, Arm pain