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Usual Care Vs Choice of Alternative Rx: Low Back Pain Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Usual Care Vs Choice of Alternative Rx: Low Back Pain conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Usual Care Vs Choice of Alternative Rx: Low Back Pain Clinical research trials and Usual Care Vs Choice of Alternative Rx: Low Back Pain medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Usual Care Vs Choice of Alternative Rx: Low Back Pain. Usual Care Vs Choice of Alternative Rx: Low Back Pain Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Usual Care Vs Choice of Alternative Rx: Low Back Pain clinical trial. Subjects typically recieve the finest healthcare available for their Usual Care Vs Choice of Alternative Rx: Low Back Pain condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "U" Clinical Trials Conditions > Usual Care Vs Choice of Alternative Rx: Low Back Pain  Usual Care Vs Choice of Alternative Rx: Low Back Pain
Usual Care Vs Choice of Alternative Rx: Low Back Pain
For Condition: Acute low back pain
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: This study compares two approaches to the management of acute low back pain: usual care (standard benefit) vs. the choice of: usual care, chiropractic, acupuncture or massage therapy (expanded benefit). 480 subjects with uncomplicated, acute low back pain will be recruited from a health maintenance organization, and randomized to either usual care (n=160) or choice of expanded benefits (n=320). Patients' preferences for individual therapies and expectations of improvement will be measured at baseline and throughout the study. Subjects randomized to the expanded benefits arm who choose chiropractic, acupuncture or massage will receive up to 10 treatments over a five-week period. Additional treatments will be available after the fifth week but will require a copayment. Treatments will be provided by licensed providers who have met strict credentialing criteria. Chiropractic, acupuncture or massage treatments will begin within 48 hours. Chiropractic, acupuncture and massage therapy scope of practice guidelines for the treatment of acute low back pain have been developed as have detailed data tracking procedures to be used at each patient visit. Symptom relief, functional status, restricted activity days, use of health care, and patient and provider satisfaction will be assessed at 2, 5,12, 26 and 52 weeks after initiation of treatment. Primary outcomes will include: 1) change in symptoms; 2) change in functional status; 3) patient satisfaction; and 4) total utilization of services associated with care for low back pain. Medical records and the HMO's cost management information system will identify use of services. It is hypothesized that patients offered their choice of expanded benefits will experience a more rapid improvement in symptoms, a faster return to baseline functional status, a decrease in utilization of conventional medical services, and will be more satisfied with their care. The study is a direct examination of the effectiveness of an insurance eligibility intervention, not a test of the efficacy of specific, non-allopathic treatment regimens. The results of this study will provide valuable information to clinicians, patients and third party payers on the relative benefits and costs of an "expanded benefits" treatment option which incorporates chiropractic, acupuncture and massage services for low back pain.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Backpain for less than 21 days - Backpain within the last 24 hours - No prior treatment or evaluation for this episode of backpain - Ability to read and speak English Exclusion Criteria: - Not low backpain - Backpain for >21 days - Already evaluated for this episode of backpain - Already treated with acupuncture, chiropractic, massage therapy, or physical therapy for this episode of backpain - Osteoporosis - Taking systemic corticosteroids - Pregnancy - History of cancer (other than non-melanoma skin cancer) - Clotting disorders or currently taking anti-coagulant medication - Severe or disabling co-exiting problem (e.g. fibromyalgia, substance abuse, rheumatoid arthritis, etc.) - Unable to read or speak English - History of back or neck surgery within the last 5 years - History of vertebral fracture or dislocation - Neurological symptoms suggestive of Cauda Equina Syndrome - Requires immediate referral to specialist
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidEisenberg, Principal Investigator, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Andrea Hrbek 617-632-7741
Additional Information:
Study ID Numbers: 1 R01 AT00144-01M; 1 R01 AT00144-01
Study Start Date: September 1999
Record last reviewed: October 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010985
Other Acute Low Back Pain Studies:
1. Usual Care Vs Choice of Alternative Rx: Low Back Pain
2. Psychosocial Treatment for Acute Low Back Pain
Related Studies:
Other Acute low back pain Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Usual Care Vs Choice of Alternative Rx: Low Back Pain
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