Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
270 participants
INTERVENTIONAL
2001-03-31
2005-02-28
Brief Summary
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Detailed Description
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1. rehabilitative exercise
2. chiropractic spinal manipulation combined with rehabilitative exercise
3. self-care education (a minimal intervention control)
The primary aim of this study is to examine the relative efficacy of the three interventions in terms of patient-rated outcomes in the short term (after 12 weeks) and long term (after 52 weeks) for chronic neck pain. Secondary aims are to assess the relative cost-effectiveness and cost utility of the three treatments, evaluate changes in objective cervical spine function, assess if cervical function is associated with changes in patient-rated outcomes, identify predictors of outcome and finally, to describe patients' interpretations of outcome measures used in clinical trials.
Using previously demonstrated recruitment methods, 270 participants with chronic neck pain will be recruited. Self-reported outcome measures will be collected at baseline and 4, 12, 26 and 52 weeks; objective outcome measures will be assessed by blinded examiners at baseline and 12 weeks.
Chiropractic investigators from Northwestern Health Sciences University are collaborating with medical clinicians from the University of Minnesota, the Minneapolis Medical Research Foundation, and the Pain Assessment and Rehabilitation Center. This established team of investigators will work together in all phases of this innovative study, leading to dissemination and publication of study results and hypothesis generation for future research. This trial will yield important information allowing health care practitioners, policy makers and patients to make better-informed decisions regarding treatment choices for chronic neck pain. Importantly, it will serve to increase the extremely limited research that currently exists for this significant health-care condition.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Chiropractic + Supervised Rehabilitative Exercise
Chiropractic care will include manual spinal manipulation, with light soft tissue massage as indicated to facilitate the spinal manipulative therapy. The spinal levels treated will be determined by the individual chiropractors by static and/or motion palpation.
Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.
2
Supervised Rehabilitative Exercise
Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.
3
Self-care education
Self-care education will be provided by the therapist trained in the study protocol. Two, one-hour sessions will be given regarding self-care measures and ergonomics relative to work and activities of daily living. These will include postural instructions and practical demonstrations of proper body mechanics performed with patient participation.
Interventions
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Chiropractic + Supervised Rehabilitative Exercise
Chiropractic care will include manual spinal manipulation, with light soft tissue massage as indicated to facilitate the spinal manipulative therapy. The spinal levels treated will be determined by the individual chiropractors by static and/or motion palpation.
Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.
Supervised Rehabilitative Exercise
Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.
Self-care education
Self-care education will be provided by the therapist trained in the study protocol. Two, one-hour sessions will be given regarding self-care measures and ergonomics relative to work and activities of daily living. These will include postural instructions and practical demonstrations of proper body mechanics performed with patient participation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Health Resources and Services Administration (HRSA)
FED
Berman Center for Outcomes and Clinical Research
OTHER
Northwestern Health Sciences University
OTHER
Principal Investigators
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Gert Bronfort, DC, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Health Sciences University
Locations
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Wolfe-Harris Center for Clinical Studies
Bloomington, Minnesota, United States
Countries
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References
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Evans R, Bronfort G, Schulz C, Maiers M, Bracha Y, Svendsen K, Grimm R, Garvey T, Transfeldt E. Supervised exercise with and without spinal manipulation performs similarly and better than home exercise for chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2012 May 15;37(11):903-14. doi: 10.1097/BRS.0b013e31823b3bdf.
Related Links
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Related Info
Other Identifiers
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R18HP10013
Identifier Type: -
Identifier Source: org_study_id