Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Brigham and Women's Hospital
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01595451
First received: May 8, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Chronic Low Back Pain
Low Back Pain
Back Pain
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Pain improvement in patients with lower back pain [ Time Frame: 6 week study ] [ Designated as safety issue: No ]
    Acupuncture in patients with lower back pain


Estimated Enrollment: 88
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional Acupuncture
Acupuncture will be delivered to 12 points traditionally used to treat chronic low back pain.
Procedure: Acupuncture
A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
Placebo Comparator: Non-traditional Acupuncture
You will receive non-traditional acupuncture at 12 points for chronic low back pain.
Procedure: Acupuncture
A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 any condition. Because we are using a placebo needle as a control, acupuncture-naive patients are necessary to maximize the benefits of blinding and to control expectancy.

    f) The intent to undergo surgery during the time of involvement in the study. g) 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 prescription opioids or steroids for pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595451

Contacts
Contact: Andrew J Dolman, MA 617-726-0324 adolman@partners.org

Locations
United States, Massachusetts
MGH - Martinos Center Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Andrew J Dolman, MA    617-726-0324    adolman@partners.org   
Principal Investigator: Robert Edwards, Ph.D.         
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Robert Edwards, Ph.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Ajay D. Wasan,M.D.,M.Sc., Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01595451     History of Changes
Other Study ID Numbers: 2011P000757
Study First Received: May 8, 2012
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Acupuncture
Back Pain
Lower Back Pain
Brigham and Women's Hospital
Massachusetts General Hospital
Effects of Acupuncture

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014