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Usual Care Vs Choice of Alternative Rx: Low Back Pain

Primary Purpose

Acute Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Chiropractic
massage
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Low Back Pain focused on measuring Backpain, Pain, Alternative Medicine, Acupuncture, Chiropractic, Massage Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harvard Medical School Osher Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
March 5, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00010985
Brief Title
Usual Care Vs Choice of Alternative Rx: Low Back Pain
Official Title
Usual Care Vs Choice of Alternative Rx: Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Low Back Pain
Keywords
Backpain, Pain, Alternative Medicine, Acupuncture, Chiropractic, Massage Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Type
Procedure
Intervention Name(s)
Chiropractic
Intervention Type
Procedure
Intervention Name(s)
massage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Eisenberg, MD
Organizational Affiliation
Harvard Medical School Osher Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Medical School Osher Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Usual Care Vs Choice of Alternative Rx: Low Back Pain

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