Brain Mechanisms of Acupuncture Treatment 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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We are doing this study to investigate the effects of acupuncture on chronic low back pain.
We are interested in learning about brain activity during pain. We plan to look at brain
activity at the beginning and the end of the study, after 6 sessions of acupuncture
treatment. You will be randomly assigned to one of two groups to receive either real or
placebo acupuncture.

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.


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.

- 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:

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

- 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.
We found this trial at
1
site
Charlestown, Massachusetts 02129
Principal Investigator: Robert Edwards, Ph.D.
Phone: 617-726-0324
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mi
from
Charlestown, MA
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