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Usual Care Vs Choice of Alternative Rx: Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010985
First received: February 2, 2001
Last updated: March 5, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Acute Low Back Pain
Procedure: Acupuncture
Procedure: Chiropractic
Procedure: massage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Usual Care Vs Choice of Alternative Rx: Low Back Pain

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: September 1999
Estimated Study Completion Date: August 2003
Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010985

Locations
United States, Massachusetts
Harvard Medical School Osher Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Investigators
Principal Investigator: David Eisenberg, MD Harvard Medical School Osher Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00010985     History of Changes
Obsolete Identifiers: NCT00008918
Other Study ID Numbers: R01 AT000144-01M, R01 AT000144-01
Study First Received: February 2, 2001
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Backpain
Pain
Alternative Medicine
Acupuncture
Chiropractic
Massage Therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014