Clinical trial NCT01614639: Brain Imaging Study of Acupuncture in Chronic Low Back Pain
Official title: A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Back Pain Lower Back Chronic
Low Back Pain, Recurrent
Keywords: Acupuncture
fMRI
CLBP
Pain
Low Back Pain
Back Pain
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2012-06-08
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brain changes to acupuncture
timeFrame: 3 visits
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: MGH - Martinos Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Robert R Edwards, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: