Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain

We are doing this study to investigate the effects of acupuncture on chronic low back pain. We are interested in learning about brain activity during pain. We plan to look at brain activity at the beginning and the end of the study, after 6 sessions of acupuncture treatment. You will be randomly assigned to one of two groups to receive either real or placebo acupuncture.

Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. Acupuncture may relieve pain by changing activity in the nervous system. Some studies indicate that acupuncture may relieve the low back pain. However, we need more research to see how well acupuncture works to relieve pain for people with this condition.

In this study, we will measure your brain activity before and after you do exercises to make your back pain worse. We will also measure your brain activity while inflating a pressure cuff device on your lower leg. We will measure this brain activity using a research tool called functional MRI (fMRI). Functional MRI is a very fast MRI that uses radio waves and a magnet, and allows the study investigators to look at changes in blood flow to different parts of the brain when there are changes in brain activity.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 79
• 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 the chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
• Subjects must be able to provoke or exacerbate their cLBP using our calibrated exercise-like maneuver.
• At least 4/10 clinical pain on the 11-point LBP severity 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.
• Right handed individuals
• 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 subject's medical record.

Exclusion Criteria:

• Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)
• Complicated back problems (e.g., prior back surgery, medico-legal 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 treatment difficult (e.g., paralysis, psychoses, or other severe psychiatric problems based on the judgment of a physician investigator and/or a T score >60 on the psychological assessments performed during Session 1)
• Prior acupuncture treatment for back pain; 1 year minimum for any other condition.
• The intent to undergo surgery during the time of involvement in the study.
• History of cardiac, respiratory, or nervous system disease that, in the judgment of a physician investigator, precludes participation in the study because of a heightened potential for adverse outcome (e.g., asthma, claustrophobia)
• Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of closed spaces, pregnancy)
• Active substance abuse disorders within the last 24 months, based on subject self-report
• Unresolved medical legal/disability/workers compensation claims
• Radicular knee pain extending below the knee
• Use of more than 60 mg morphine equivalent prescription opioids or steroids for pain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Traditional Acupuncture; Acupuncture will be delivered to 12 points traditionally used to treat chronic low back pain.	Procedure: Acupuncture; A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
PLACEBO_COMPARATOR: Non-traditional Acupuncture; You will receive non-traditional acupuncture at 12 points for chronic low back pain.	Procedure: Acupuncture; A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain improvement in patients with lower back pain	Acupuncture in patients with lower back pain	6 week study

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 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 8, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (ESTIMATE): May 10, 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: Acupuncture; Back Pain; Lower Back Pain; Massachusetts General Hospital; Brigham and Women's Hospital; Effects of Acupuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2011P000757