Brain Imaging Study of Acupuncture in Chronic Low Back Pain



Status:Completed
Conditions:Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 60
Updated:12/1/2017
Start Date:January 2012
End Date:October 2017

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A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients.

We are doing this research study to learn about how acupuncture treatment works. This study
is being done to look at changes in the brain, NOT to treat pain. We want to learn about
brain activity during acupuncture. We will look at brain activity when a heating device
touches the skin of a subject before and after the subject has acupuncture, to see what
changes.


Inclusion Criteria:

- Meet the Classification Criteria of 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 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:

- Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)

- 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.
We found this trial at
1
site
Charlestown, Massachusetts 02129
Principal Investigator: Ajay D Wasan, M.D
Phone: 617-732-9486
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mi
from
Charlestown, MA
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