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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

May 23, 2012
April 2, 2014
January 2012
September 2016   (final data collection date for primary outcome measure)
Brain changes to acupuncture [ Time Frame: 3 visits ] [ Designated as safety issue: No ]
The effects of pain on the brain
Subjective reports of pain, fMRI signal changes in the brain. [ Time Frame: up to 27 days ] [ Designated as safety issue: Yes ]
The effects of pain on the brain
Complete list of historical versions of study NCT01614639 on ClinicalTrials.gov Archive Site
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Brain Imaging Study of Acupuncture in Chronic Low Back Pain
A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients.

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Low Back Pain
  • Back Pain Lower Back Chronic
  • Low Back Pain, Recurrent
Procedure: Acupuncture
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
  • Experimental: Traditional Acupuncture
    Traditional Acupuncture given at 2 visits.
    Intervention: Procedure: Acupuncture
  • Experimental: Electroacupuncture
    Electro-acupuncture given at 2 visits.
    Intervention: Procedure: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
138
December 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
United States
 
NCT01614639
2011P000748, P01AT006663-01
Yes
Robert Edwards, Brigham and Women's Hospital
Brigham and Women's Hospital
  • Massachusetts General Hospital
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Robert R Edwards, Ph.D. Brigham and Women's Hospital
Brigham and Women's Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP