Neck Pain Clinical Trial
Official title:
Manipulation, Exercise, and Self-Care for Neck Pain
The purpose of this study is to compare three treatments for neck pain: 1) rehabilitative exercise, 2) chiropractic spinal manipulation combined with rehabilitative exercise, and 3) self-care education.
Status | Completed |
Enrollment | 270 |
Est. completion date | February 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Chronic mechanical neck pain (defined as current episode > 12 weeks' duration). - Quebec Task Force classifications 1, 2, 3 and 4. This includes patients with neck pain, stiffness or tenderness, with or without musculoskeletal and neurological signs. Exclusion Criteria: - Previous cervical spine surgery - Neck pain referred from local joint lesions of the lower extremities or from visceral diseases - Progressive neurological deficits due to nerve root or spinal cord compression - Existing cardiac disease requiring medical treatment - Blood clotting disorders - Diffuse idiopathic hyperostosis - Infectious and non-infectious inflammatory or destructive tissue changes of the cervical spine - Presence of significant infectious disease, or other severe disabling health problems - Substance abuse - Ongoing treatment for neck pain by other health care providers - Pregnant or nursing women - Average neck pain score of less than 30 percentage points - Pending or current litigation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Wolfe-Harris Center for Clinical Studies | Bloomington | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Northwestern Health Sciences University | Berman Center for Outcomes and Clinical Research, Health Resources and Services Administration (HRSA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient rated pain(0-10 scale,11 box) | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Neck Disability Index (NDI)at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | General health status at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Improvement (Global Change)at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Disability Days at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Bothersomeness of Symptoms at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Frequency of Symptoms at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Patient Satisfaction at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Depression at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Medication use at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Fear-Avoidance Beliefs at baseline, weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | Cervical range of motion at baseline, weeks 4,12 | short term = 12 weeks | ||
Secondary | Cervical Strength and Endurance at baseline, weeks 4,12 | short term = 12 weeks | ||
Secondary | Health Care Costs and Utilization at weeks 4,12,26,52 | short term = 12 weeks; long term = 52 weeks | ||
Secondary | In-depth Interview at week 12 | 12 weeks |
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