Central Mechanisms of Intervention for Low Back Pain
Tracking Information | |||||||||
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First Received Date ICMJE | July 26, 2011 | ||||||||
Last Updated Date | August 23, 2012 | ||||||||
Start Date ICMJE | August 2012 | ||||||||
Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01406847 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Change in Physical Impairment Index [ Time Frame: 48 hours post-intervention ] [ Designated as safety issue: No ] Physical Impairment Index is a group of tests including trunk and limb range of motion, muscle tenderness and abdominal muscle performance |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Central Mechanisms of Intervention for Low Back Pain | ||||||||
Official Title ICMJE | Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain | ||||||||
Brief Summary | Body-based interventions have consistently shown clinical effectiveness in patients with back pain. The primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central sensitization of pain. Participants will be randomly assigned to receive one of the interventions or be in a control group. The central hypothesis for this proposal is that spinal manipulation, a specific form of body-based intervention, inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other interventions. The completion of the proposed study will elucidate underpinning mechanisms of body-based interventions. Identification of these mechanisms will improve the clinical application and utilization of these interventions in the management of musculoskeletal pain conditions, especially back pain. |
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Detailed Description | 170 participants will be randomly assigned to receive one of the interventions or be in a control group. The investigators will use of a model of experimentally induced low back pain to investigate the effects of manipulative and body-based interventions in acute onset low back pain without some of the clinical confounds. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the induction of pain, and before and after interventions for that pain. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE | Low Back Pain | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* 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 | Recruiting | ||||||||
Estimated Enrollment ICMJE | 170 | ||||||||
Estimated Completion Date | March 2016 | ||||||||
Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 40 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01406847 | ||||||||
Other Study ID Numbers ICMJE | 439-2010, 1R01AT006334-01 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | University of Florida | ||||||||
Study Sponsor ICMJE | University of Florida | ||||||||
Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
Investigators ICMJE |
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Information Provided By | University of Florida | ||||||||
Verification Date | August 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |