Brain Imaging Study of Acupuncture in Chronic Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Brigham and Women's Hospital
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01614639
First received: May 23, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Low Back Pain
Back Pain Lower Back Chronic
Low Back Pain, Recurrent
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Brain changes to acupuncture [ Time Frame: 3 visits ] [ Designated as safety issue: No ]
    The effects of pain on the brain


Estimated Enrollment: 138
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
Experimental: Traditional Acupuncture
Traditional Acupuncture given at 2 visits.
Procedure: Acupuncture
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
Experimental: Electroacupuncture
Electro-acupuncture given at 2 visits.
Procedure: Acupuncture
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  • 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 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: NCT01614639

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

No publications provided

Responsible Party: Robert Edwards, Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01614639     History of Changes
Other Study ID Numbers: 2011P000748, P01AT006663-01
Study First Received: May 23, 2012
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Acupuncture
fMRI
CLBP
Pain
Low Back Pain
Back Pain

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

ClinicalTrials.gov processed this record on October 20, 2014