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Usual Care Vs Choice of Alternative Rx: Low Back Pain Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Usual Care Vs Choice of Alternative Rx: Low Back Pain conditions. Clinical Trials Search.org is a site devoted 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 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 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 volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Usual Care Vs Choice of Alternative Rx: Low Back Pain clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Usual Care Vs Choice of Alternative Rx: Low Back Pain condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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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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