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NCT00010985 · ClinicalTrials.gov registry record · Phase 3
Usual Care Vs Choice of Alternative Rx: Low Back Pain
A Phase 3 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 3
- Development phase
NCT00010985 is a Phase 3 study that has completed, run by National Center for Complementary and Integrative Health (NCCIH).
The verdict
NCT00010985, a Phase 3 study, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 3
- Development phase
Study 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 eligibilit
Interventions
- PROCEDURE Acupuncture
- PROCEDURE Chiropractic
- PROCEDURE massage
Trial Details
| Field | Value |
|---|---|
| Start Date | 1999-09 |
| Est. Completion | 2003-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00010985
The ClinicalTrials.gov registry entry for NCT00010985 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Acupuncture is the first listed.
NCT00010985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00010985 about?
NCT00010985 is a clinical study titled "Usual Care Vs Choice of Alternative Rx: Low Back Pain". 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 ...
What is the current status of trial NCT00010985?
This trial is currently completed. It is a Phase 3 study. The study started on 1999-09. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00010985?
The interventions under investigation include: Acupuncture (PROCEDURE), Chiropractic (PROCEDURE), massage (PROCEDURE).
Who is sponsoring clinical trial NCT00010985?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
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