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

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.

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.