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
151 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
TREATMENT
DOUBLE
Study Groups
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Traditional Acupuncture
Participants will receive acupuncture over 6 30-minute sessions.
Traditional Acupuncture
Laser Acupuncture
Participants will receive laser acupuncture over 6 30-minute sessions.
Laser Acupuncture
Wait-List
Subjects will be put on a 6 week wait-list and receive vouchers for acupuncture at a local clinic.
No interventions assigned to this group
Interventions
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Traditional Acupuncture
Laser Acupuncture
Eligibility Criteria
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Inclusion Criteria
* Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
* At least 4/10 clinical pain on the 11-point LBP intensity scale.
* Patients must be able to provoke or exacerbate their chronic LBP using our calibrated exercise-like maneuver.
* Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record.
* 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.
Exclusion Criteria
* 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 acupuncture intervention effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
* Conditions making acupuncture difficult (e.g. paralysis, psychoses),
* Prior acupuncture treatment for back pain; 1 year wait for any other type.
* The intent to undergo surgery during the time of involvement in the study.
* History of cardiac, respiratory, or nervous system disease that, in Dr. Wasan'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.
* Involvement in workmen's compensation or disability claims.
* Radicular pain extending below the knee.
* Active substance abuse disorders within the last 24 months, based on subject self-report.
* Use of more than 60 mg morphine equivalent 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
Principal 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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2011P001364
Identifier Type: -
Identifier Source: org_study_id