Brain Imaging Study of Acupuncture in Chronic Low Back Pain

November 27, 2017 updated by: Robert Edwards, Brigham and Women's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • MGH - Martinos Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain changes to acupuncture
Time Frame: 3 visits
The effects of pain on the brain
3 visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Robert R Edwards, Ph.D., Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P000748
  • P01AT006663-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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