Clinical trial NCT01595451: Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain
Official title: Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Low Back Pain
Back Pain
Keywords: Acupuncture
Back Pain
Lower Back Pain
Brigham and Women's Hospital
Massachusetts General Hospital
Effects of 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: 2012-05-10
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain improvement in patients with lower back pain
timeFrame: 6 week study
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 Edwards, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: