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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00118859 |
This pilot study will determine the feasibility of enrolling participants from different populations for a larger study of low back pain (LBP) treatment. In addition, this study will assess the effectiveness of data collection instruments and procedures as well as utilize feedback from participants to refine a future study.
Condition | Intervention |
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Low Back Pain |
Behavioral: Integrative care for low back pain Behavioral: Conventional treatment for low back pain |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Model of Integrative Care in an Academic Health Center |
Estimated Enrollment: | 60 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | April 2006 |
Back pain is one of the most common health problems in the United States, afflicting up to 50% of adults each year. Back pain is the leading cause of visits to orthopedic surgeons and the second leading cause of visits to general practitioners. In the United States, the estimated annual cost of back pain, including medical costs and lost productivity, is between $50 and $100 billion. Unfortunately, conventional medical care has been largely ineffective in treating back pain of most people. An increasing number of people with back pain, particularly with LBP, are seeking relief from unconventional sources such as chiropractors and massage therapies. Although complementary and alternative medicine (CAM) therapies are being used to treat LBP, their effectiveness has not been thoroughly examined. Even less is known about the effectiveness of combining conventional medical care with CAM therapies to provide “integrative care.” This pilot study will recruit participants from three different patient populations to determine the effectiveness of integrative care in treating LBP symptoms.
This study will last 26 weeks and will comprise three participant populations: patients at an occupational health clinic, primary care patients at a medical clinic, and workers' compensation patients at the same medical clinic.
At study start, participants will be interviewed about the care they have already received for LBP, any activities limited by their LBP, their attitudes toward CAM back pain treatments, job satisfaction, social support in the workplace, and medical history. Participants will also complete a self-report pain scale and a disability questionnaire. Participants will then be randomly assigned to either receive treatment for their LBP at an Integrative Care Center or continue to receive usual care provided by their medical or occupational health clinic.
Participants assigned to receive integrative care will be evaluated by both a medical doctor and a CAM clinician immediately after being interviewed. Following the evaluation, the two clinicians will meet and develop a treatment plan, which will include conventional medical care and some form of CAM such as acupuncture, chiropractic, exercise, massage, mind-body therapy, or nutritional counseling. Treatments will occur either once or twice weekly for the 12-week duration of treatment; clinicians may revise treatment plans during the study.
LBP symptoms will be assessed through phone interviews at Weeks 2, 5, 12, and 26.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | RO1 AT000905, ICC |
Study First Received: | July 7, 2005 |
Last Updated: | February 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00118859 History of Changes |
Health Authority: | United States: Federal Government |
Back Pain Integrative Care Acupuncture Chiropractic Exercise |
Massage Therapy Mind-Body Therapy Nutritional Counseling Complementary Therapies Complementary and Alternative Medicine |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
Low Back Pain Pain Back Pain |