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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Low Back Pain, Recurrent; Back Pain Lower Back Chronic
• Intervention / Treatment: Procedure: Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	The effects of pain on the brain	3 visits

Collaborators and Investigators

• 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

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: Pain; Low Back Pain; Acupuncture; fMRI; Back Pain; CLBP
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• 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