Back Pain Response to Different Acupuncture Methods (LBP)
This study is currently recruiting participants.
Verified April 2013 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01598974
First received: May 11, 2012
Last updated: April 22, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | May 11, 2012 | ||||
| Last Updated Date | April 22, 2013 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | September 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain improvement in patients with lower back pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] Pain rating changes for chronic low back pain after acupuncture sessions. |
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| Original Primary Outcome Measures ICMJE |
Back pain severity assessment will be used to determine the effects of acupuncture for Lower Back Pain. [ Time Frame: Six Weeks ] [ Designated as safety issue: No ] Low back pain severity rating, cerebral blood flow (CBF) changes as measured by arterial spin labeling (ASL) |
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| Change History | Complete list of historical versions of study NCT01598974 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 | Back Pain Response to Different Acupuncture Methods | ||||
| Official Title ICMJE | Brain Plasticity Underlying Back Pain Response to Different Acupuncture Methods | ||||
| Brief Summary | Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. We are doing this study to learn about the effects of different forms of acupuncture on chronic low back pain. We are interested in learning about brain activity during pain. We plan to look at brain activity at the beginning and the end of the study, after 6 sessions of acupuncture. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Lower 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 129 | ||||
| Estimated Completion Date | December 2016 | ||||
| Estimated Primary Completion Date | September 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 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01598974 | ||||
| Other Study ID Numbers ICMJE | 2011P001364 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital | ||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||
| Verification Date | April 2013 | ||||
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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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