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| Sponsor: | Palmer College of Chiropractic |
|---|---|
| Collaborator: |
Department of Health and Human Services |
| Information provided by: | Palmer College of Chiropractic |
| ClinicalTrials.gov Identifier: | NCT00285649 |
Purpose
The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic LBP.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Procedure: Spinal Manipulation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Predicting Patients' Response to Spinal Manipulation |
| Enrollment: | 240 |
| Study Start Date: | July 2004 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
|
Procedure: Spinal Manipulation
HVLA-SM, LVVA-SM
Other Name: Celebrex, Aleve, Bextra, Naptoxen,
|
|
Experimental: 2
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
|
Procedure: Spinal Manipulation
HVLA-SM, LVVA-SM
Other Name: Celebrex, Aleve, Bextra, Naptoxen,
|
|
Active Comparator: 3
Usual Medical Care, Active Comparator, advice, exercises and medications
|
Procedure: Spinal Manipulation
HVLA-SM, LVVA-SM
Other Name: Celebrex, Aleve, Bextra, Naptoxen,
|
Despite the high prevalence of LBP and the associated economic costs, disability, and lost productivity, and despite the development of several treatment guidelines, one of which recommends chiropractic spinal manipulation for some subgroups of patients with back pain, the management of LBP remains controversial and highly variable across professions and geographic regions. Although one recent publication describes the design of chiropractic and exercise for seniors with low back or neck pain, no published studies, to our knowledge, have assessed the effectiveness of chiropractic manipulation compared to medical care for older adults with sub-acute or chronic low back pain.
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Iowa | |
| Palmer Center for Chiropractic Research | |
| Davenport, Iowa, United States, 52803 | |
| Principal Investigator: | William C Meeker, DC, M.P.H. | Palmer Chiropractic College |
| Principal Investigator: | David Wilder, PhD | The University of Iowa |
More Information
| Responsible Party: | William C. Meeker, Palmer College of Chiropractic |
| ClinicalTrials.gov Identifier: | NCT00285649 History of Changes |
| Other Study ID Numbers: | U19P3, U19 AT0002006 |
| Study First Received: | January 31, 2006 |
| Last Updated: | August 31, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Spinal Manipulation |
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |