Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain
NCT ID: NCT01595451
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
79 participants
INTERVENTIONAL
2012-01-31
2017-10-31
Brief Summary
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Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. Acupuncture may relieve pain by changing activity in the nervous system. Some studies indicate that acupuncture may relieve the low back pain. However, we need more research to see how well acupuncture works to relieve pain for people with this condition.
In this study, we will measure your brain activity before and after you do exercises to make your back pain worse. We will also measure your brain activity while inflating a pressure cuff device on your lower leg. We will measure this brain activity using a research tool called functional MRI (fMRI). Functional MRI is a very fast MRI that uses radio waves and a magnet, and allows the study investigators to look at changes in blood flow to different parts of the brain when there are changes in brain activity.
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
Acupuncture will be delivered to 12 points traditionally used to treat chronic low back pain.
Acupuncture
A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
Non-traditional Acupuncture
You will receive non-traditional acupuncture at 12 points for chronic low back pain.
Acupuncture
A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
Interventions
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Acupuncture
A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
Eligibility Criteria
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Inclusion Criteria
* Subjects must be able to provoke or exacerbate their cLBP using our calibrated exercise-like maneuver.
* At least 4/10 clinical pain on the 11-point LBP severity 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.
* Right handed individuals
* 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 subject's medical record.
Exclusion Criteria
* Complicated back problems (e.g., prior back surgery, medico-legal 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 treatment difficult (e.g., paralysis, psychoses, or other severe psychiatric problems based on the judgment of a physician investigator and/or a T score \>60 on the psychological assessments performed during Session 1)
* Prior acupuncture treatment for back pain; 1 year minimum for any other condition.
* The intent to undergo surgery during the time of involvement in the study.
* History of cardiac, respiratory, or nervous system disease that, in the judgment of a physician investigator, precludes participation in the study because of a heightened potential for adverse outcome (e.g., asthma, claustrophobia)
* Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of closed spaces, pregnancy)
* Active substance abuse disorders within the last 24 months, based on subject self-report
* Unresolved medical legal/disability/workers compensation claims
* Radicular knee pain extending below the knee
* Use of more than 60 mg morphine equivalent prescription opioids or steroids for pain.
18 Years
60 Years
ALL
No
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 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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2011P000757
Identifier Type: -
Identifier Source: org_study_id