Clinical trial NCT01598974: Back Pain Response to Different Acupuncture Methods
Official title: Brain Plasticity Underlying Back Pain Response to Different Acupuncture Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Keywords: Lower Back Pain
Acupuncture
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: 2012-05-15
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. We are doing this study to learn about the effects of different forms 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.


Eligibility criteria: Inclusion Criteria:

* Volunteers 18-60 years of age.
* 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:

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

Primary outcomes:
measure: Pain improvement in patients with lower back pain
timeFrame: 6 weeks
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: