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Brain Imaging Study of Acupuncture in Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01614639
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : November 29, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Low Back Pain Back Pain Lower Back Chronic Low Back Pain, Recurrent Procedure: Acupuncture

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients.
Actual Study Start Date : January 2012
Primary Completion Date : May 2017
Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Brain changes to acupuncture [ Time Frame: 3 visits ]
    The effects of pain on the brain

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 back pain; 1 year minimum wait for any condition other condition.
  • 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 more than 60 mg prescription opioids or steroids for pain.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614639

United States, Massachusetts
MGH - Martinos Center
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Robert R Edwards, Ph.D. Brigham and Women's Hospital
More Information

Responsible Party: Robert Edwards, Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01614639     History of Changes
Other Study ID Numbers: 2011P000748
P01AT006663-01 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by Robert Edwards, Brigham and Women's Hospital:
Low Back Pain
Back Pain

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