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Sponsors and Collaborators: |
Northwestern Health Sciences University Health Resources and Services Administration (HRSA) Berman Center for Outcomes and Clinical Research |
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Information provided by: | Northwestern Health Sciences University |
ClinicalTrials.gov Identifier: | NCT00269308 |
The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.
Condition | Intervention | Phase |
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Neck Pain |
Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior) Procedure: Supervised rehabilitative exercise + home exercise Behavioral: Home exercise |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individual 65 and Over With Chronic Mechanical Neck Pain |
Estimated Enrollment: | 240 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | July 2008 |
Arms | Assigned Interventions |
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1: Experimental
Chiropractic Manual Treatment + Home Exercise
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Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior)
The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation and mobilization with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active |
2: Experimental
Supervised Rehabilitative Exercise + Home Exercise
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Procedure: Supervised rehabilitative exercise + home exercise
The rehabilitative exercise program will consist of 20, 1 hour small-group sessions. It is a modification of exercise protocols used in previous studies by the investigators and others and incorporates recommendations of leading rehabilitative exercise specialists. The program will include exercises that reduce joint stiffness and relax elastic structures resulting in lower joint loads during movements. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active |
3: Active Comparator
Home Exercise
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Behavioral: Home exercise
Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
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Neck pain (NP) is a considerable health problem, affecting both young and elderly individuals. Of particular concern is the negative impact NP may have on the functional ability of the geriatric population, already challenged by decreased mobility and balance associated with ageing. Chiropractic manual treatment and rehabilitative exercise have demonstrated potential for the treatment of NP in younger individuals, but have yet to be rigorously tested in the elderly.
The broad, long-term objective of this research is to identify effective therapies for patients, 65 years and older, who suffer with chronic neck pain and to enhance their functional capacity. Primary Aims
To estimate the short- and long-term relative effectiveness of the three interventions using:
This project is a collective effort by a multidisciplinary team, with an established record of collaborative research in the area of neck and back pain.
The results of this study will provide valuable information for elderly neck pain sufferers and the clinicians who treat them.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University | |
Bloomington, Minnesota, United States, 55431 |
Principal Investigator: | Gert Bronfort, DC, PhD | Northwestern Health Sciences University |
Study ID Numbers: | R18HP01425 |
Study First Received: | December 21, 2005 |
Last Updated: | November 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00269308 History of Changes |
Health Authority: | United States: Institutional Review Board |
Randomized Clinical Trial Neck Pain |
Chiropractic Manual Therapies Exercise |
Signs and Symptoms Neck Pain Neurologic Manifestations Pain |
Signs and Symptoms Nervous System Diseases Neck Pain Neurologic Manifestations Pain |