Predicting Patients' Response to Spinal Manipulation
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| First Received Date ICMJE | January 31, 2006 | ||||||||
| Last Updated Date | August 31, 2009 | ||||||||
| Start Date ICMJE | July 2004 | ||||||||
| Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Roland Morris Low Back Pain Disability Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Roland Morris Low Back Pain Disability Questionnaire | ||||||||
| Change History | Complete list of historical versions of study NCT00285649 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Predicting Patients' Response to Spinal Manipulation | ||||||||
| Official Title ICMJE | Predicting Patients' Response to Spinal Manipulation | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Low Back Pain | ||||||||
| Intervention ICMJE | Procedure: Spinal Manipulation
HVLA-SM, LVVA-SM
Other Name: Celebrex, Aleve, Bextra, Naptoxen, |
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| Study Arm (s) |
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| Publications * | Hondras MA, Long CR, Haan AG, Spencer LB, Meeker WC. Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center. J Altern Complement Med. 2008 Oct;14(8):983-92. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 240 | ||||||||
| Completion Date | March 2007 | ||||||||
| Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00285649 | ||||||||
| Other Study ID Numbers ICMJE | U19P3, U19 AT0002006 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | William C. Meeker, Palmer College of Chiropractic | ||||||||
| Study Sponsor ICMJE | Palmer College of Chiropractic | ||||||||
| Collaborators ICMJE | Department of Health and Human Services | ||||||||
| Investigators ICMJE |
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| Information Provided By | Palmer College of Chiropractic | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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