Brain Imaging Study of Acupuncture in Chronic Low Back Pain
NCT ID: NCT01614639
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2012-01-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Traditional Acupuncture
Traditional Acupuncture given at 2 visits.
Acupuncture
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
Electroacupuncture
Electro-acupuncture given at 2 visits.
Acupuncture
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
Interventions
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Acupuncture
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
Eligibility Criteria
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Inclusion Criteria
* At least 4/10 clinical pain on the 10-point LBP intensity scale on average during the past two weeks prior to enrollment
* At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures
* Must have had a prior evaluation of their low back pain by a health care provider, which may include radiographic studies. Documentation of this evaluation will be obtained from the subject's medical record
Exclusion Criteria
* Radicular pain extending below the knee
* Complicated back problems (e.g., prior back surgery, medicolegal issues)
* Possible contraindications for acupuncture (e.g., coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis)
* Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator and/or a T score \> 60 on the psychological measures assessed during Session 1)
* Prior acupuncture treatment for back pain; 1 year minimum wait for any condition other condition.
* Active substance abuse disorder in the past two years, as determined by subject self-report.
* The intent to undergo surgery during the time of involvement in the study.
* History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia.
* Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
* Unresolved legal/disability/workers compensation claims in connection with low back.
* Instability of pain ratings in Session 2 or Session 3.
* Use of more than 60 mg prescription opioids or steroids for pain.
18 Years
60 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
National Center for Complementary and Integrative Health (NCCIH)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Robert Edwards
Investigator
Principal Investigators
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Robert R Edwards, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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MGH - Martinos Center
Charlestown, Massachusetts, United States
Countries
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Other Identifiers
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2011P000748
Identifier Type: -
Identifier Source: org_study_id