Z-Joint Changes in Low Back Pain Following Adjusting
| Tracking Information | |||||
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| First Received Date ICMJE | January 30, 2006 | ||||
| Last Updated Date | May 1, 2012 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Anterior to posterior measurements (A-P gap) of the Z joints. [ Time Frame: February 2006-December 2011 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00284063 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Z-Joint Changes in Low Back Pain Following Adjusting | ||||
| Official Title ICMJE | Z-Joint Changes in Low Back Pain Following Adjusting | ||||
| Brief Summary | The purpose of this continuation project is to use MRI to evaluate gapping of the zygapophysial (Z) joints following side-posture positioning and side-posture spinal adjusting in subjects with acute low back pain. |
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| Detailed Description | The purpose of this continuation project is to use MRI to evaluate gapping of the zygapophysial (Z) joints following side-posture positioning and side-posture spinal adjusting in subjects with acute low back pain (LBP). A fundamental hypothesis of one of the beneficial effects of chiropractic spinal adjusting is that adhesions, developing in the Z joints following hypomobility of these structures, are thought to be alleviated by separation (gapping) of the Z joints through spinal adjusting. In the previous study, side-posture adjusting was found to gap the Z joints in healthy subjects. The aim of this study is to determine if differences can be measured in the L4/L5 and L5/S1 Z joint spaces during side-posture positioning and after lumbar side-posture spinal adjusting of 112 subjects with acute LBP, and to determine if the amount of gapping is related to pain relief and improved function. Before any treatment begins, the subjects will be temporarily randomized into one of 4 MRI groups: 1) neutral positioning, followed by side-posture positioning (most painful side up); 2) neutral positioning, followed by side-posture adjusting (most painful side up), followed by neutral positioning; 3) neutral positioning, followed by side-posture adjusting (most painful side up) and remaining in side-posture; and 4) (pure control group) neutral positioning, followed by very brief side-posture positioning, followed by neutral positioning. MRI scans will be taken with the subjects in the original neutral position and in the final position. Both MRI scans will be conducted consecutively over approximately 30 minutes (12:19 minutes per scan). All spinal adjustments given during this appointment will be performed directly on the MRI gantry table after the first scan. A second MRI appointment will occur 2 weeks later, after 2 weeks of treatment. At the second MRI appointment, subjects will be assigned to the MRI group opposite to the one to which they were randomized during the first MRI appointment. Three observers, blinded to each other and to subject grouping, will make anterior-to-posterior measurements (A-P gap) of the Z joints directly from the MRI scans. The gapping difference between the second and first scans of each MRI appointment will be analyzed to determine if differences exist between the 4 groups. Results of the first and second MRI appointments will also be evaluated to determine if the amount of gapping is related to pain (at first MRI appointment), relief of pain (at the second MRI appointment - difference in Visual Analog Scale from initial exam to MRI appointment) and current (first MRI appointment) and change in disability (second MRI appointment - difference in Bournemouth Questionnaire scores). The results of this study will be used to increase understanding of the mechanism of action of lumbar side posture adjusting and side-posture positioning in acute LBP patients. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Mechanical Low Back Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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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 | 112 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | December 2009 (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 69 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00284063 | ||||
| Other Study ID Numbers ICMJE | 2 R01 AT000123-03 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Gregory D. Cramer, National University of Health Sciences | ||||
| Study Sponsor ICMJE | National University of Health Sciences | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National University of Health Sciences | ||||
| Verification Date | April 2012 | ||||
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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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