Usual Care Vs Choice of Alternative Rx: Low Back Pain

NCT ID: NCT00010985

Last Updated: 2008-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2003-08-31

Brief Summary

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.

Detailed Description

See brief summary

Conditions

Acute Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

Acupuncture

Intervention Type: PROCEDURE

Chiropractic

Intervention Type: PROCEDURE

massage

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

David Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School Osher Institute

Locations

Harvard Medical School Osher Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01AT000144-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01 AT000144-01M

Identifier Type: -

Identifier Source: org_study_id

NCT00008918

Identifier Type: -

Identifier Source: nct_alias