Using MRI Scans to Evaluate Spinal Manipulation
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| First Received Date ICMJE | October 9, 2003 | ||||
| Last Updated Date | August 16, 2006 | ||||
| Start Date ICMJE | June 2000 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00070902 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| 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 | Using MRI Scans to Evaluate Spinal Manipulation | ||||
| Official Title ICMJE | The Effects of Positioning and Adjusting on the Z Joint | ||||
| Brief Summary | Lumbar spinal manipulation, or chiropractic adjusting, is thought to separate the surfaces of the spinal joints and thereby relieve lower back pain. This study will use MRI scans to evaluate the spinal joints before and after spinal manipulation. |
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| Detailed Description | Zygapophysial joints, better known as facet or “Z” joints, are located on the back (posterior) of the spine on each side of the vertebrae where it overlaps the neighboring vertebrae. Z joints provide stability and allow the spine to bend and twist. Adhesions in the Z joints may develop following hypomobility of vertebrae. These adhesions may be alleviated by separation (gapping) of the Z joints. Side posture adjusting (spinal manipulation) is thought by many to gap the Z joints, yet no measurable differences of the Z joints before and after spinal manipulation have ever been published. This study will evaluate gapping of the L3/L4, L4/L5, and L5/S1 Z joints by taking measurements directly from MRI scans of the Z joints before and during positioning for a side posture adjustment, and before and after side posture adjusting. Health volunteers will be randomly assigned to one of four groups: 1) neutral position followed by side posture positioning (trunk rotated to the volunteer’s right); 2) neutral position followed by side posture spinal adjusting followed by neutral positioning; 3) neutral position followed by side posture spinal adjusting, followed by side posture positioning; and 4) neutral position followed by neutral position (control group). MRI scans will be taken with the volunteers in the original neutral position and in the final position (either second neutral position or side posture positioning). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Lower Back Pain | ||||
| Intervention ICMJE | Procedure: Lumbar side-posture spinal adjusting | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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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 | 64 | ||||
| Completion Date | October 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 29 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 | NCT00070902 | ||||
| Other Study ID Numbers ICMJE | R01 AT000123-01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | August 2006 | ||||
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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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