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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief in 140 Participants With Neck Pain

NCT06906107

Neck Pain Musculoskeletal Neck Pain Treatment Cervicalgia

RECRUITING NA

Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation

NCT06036849

Neck Pain

COMPLETED NA

Manual Therapy and Augmented Exercise for Neck Pain

NCT01750736

Neck Pain

COMPLETED NA

Chiropractic and Exercise Management of Spinal Dysfunction in Seniors

NCT01057706

Neck Disability Back Disability

COMPLETED PHASE2/PHASE3

Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study

NCT03863769

Spinal Stenosis Lumbar

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neck Pain Pain in Arm, Unspecified

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Manual Cervical Distraction High Force

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.

Group Type ACTIVE_COMPARATOR

Manual Cervical Distraction

Intervention Type PROCEDURE

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.

Manual Cervical Distraction Medium Force

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.

Group Type ACTIVE_COMPARATOR

Manual Cervical Distraction

Intervention Type PROCEDURE

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.

Manual Cervical Distraction Low Force

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.

Group Type SHAM_COMPARATOR

Manual Cervical Distraction

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Manual Cervical Distraction

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No