Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)
This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01094782
First received: March 19, 2010
Last updated: May 23, 2013
Last verified: May 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 19, 2010 | ||||||||
| Last Updated Date | May 23, 2013 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Changes in QST measures in response to acupuncture [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupunture treatment. |
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| Original Primary Outcome Measures ICMJE |
Changes in QST measures in response to acupuncture [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] Changes in heat pain threshold and tolerance, as measured by quantitative sensory testing (QST), in response to acupunture treatment |
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| Change History | Complete list of historical versions of study NCT01094782 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 | Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST) | ||||||||
| Official Title ICMJE | Evaluating the Effect of Acupuncture on Pain Relief Using QST | ||||||||
| Brief Summary | The purpose of this study is to explore a new approach to assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions. |
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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: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic |
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| Condition ICMJE | 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 | 150 | ||||||||
| Estimated Completion Date | January 2015 | ||||||||
| Estimated Primary Completion Date | January 2014 (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 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01094782 | ||||||||
| Other Study ID Numbers ICMJE | 2009P 0001551, RO1-AT005819 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jianren Mao, MD, PhD, Massachusetts General Hospital | ||||||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||||||
| Verification Date | May 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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