N/A
N=48
Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial
Neck Pain · Pain in Arm, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT01765751 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Range of Traction Forces — 13.82; 38.3; 65.08; 17.19 Newtons (N)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Manual Cervical Distraction (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Palmer College of Chiropractic
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Range of Traction Forces |
13.82; 38.3; 65.08; 17.19; 42.87; 74.06 | — |
| SECONDARY Neck Disability Index (NDI) |
1.3; 4.2; 4.0 | — |
| SECONDARY Neck Pain Visual Analogue Scale (VAS) |
9.1; 18.9; 24.7 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS-43) |
53.2; 54.9; 51.2; 50.0; 49.6; 51.6 | — |
| SECONDARY Cervical Range of Motion (cROM). |
70.2; 75.4; 78.6; 51.6; 54.7; 49.8 | — |
| SECONDARY Procedure Believability Questionnaire |
3; 6; 3; 5; 5; 8 | — |
| SECONDARY Credibility and Expectancy Questionnaire (CEQ) |
19.8; 23.1; 21.0; 15.5; 19.9; 22.1 | — |
Summary
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.
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.
Data sourced from ClinicalTrials.gov (NCT01765751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.