Back Pain Response to Different Acupuncture Methods (LBP)

Brain Plasticity Underlying Back Pain Response to Different Acupuncture Methods

Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. We are doing this study to learn about the effects of different forms 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.

Study Overview

• Status: Completed
• Conditions: Lower Back Pain
• Intervention / Treatment: Procedure: Traditional Acupuncture; Procedure: Laser Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 151
• 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: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Volunteers 18-60 years of age.
• Meet the Classification Criteria of the 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 11-point LBP intensity scale.
• Patients must be able to provoke or exacerbate their chronic LBP using our calibrated exercise-like maneuver.
• Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record.
• 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.

Exclusion Criteria:

• Specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections),
• 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 acupuncture intervention effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
• Conditions making acupuncture difficult (e.g. paralysis, psychoses),
• Prior acupuncture treatment for back pain; 1 year wait for any other type.
• The intent to undergo surgery during the time of involvement in the study.
• History of cardiac, respiratory, or nervous system disease that, in Dr. Wasan'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.
• Involvement in workmen's compensation or disability claims.
• Radicular pain extending below the knee.
• Active substance abuse disorders within the last 24 months, based on subject self-report.
• 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 Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional Acupuncture; Participants will receive acupuncture over 6 30-minute sessions.	Procedure: Traditional Acupuncture
Experimental: Laser Acupuncture; Participants will receive laser acupuncture over 6 30-minute sessions.	Procedure: Laser Acupuncture
No Intervention: Wait-List; Subjects will be put on a 6 week wait-list and receive vouchers for acupuncture at a local clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain improvement in patients with lower back pain	Pain rating changes for chronic low back pain after acupuncture sessions.	6 weeks

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 11, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 15, 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; Lower Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2011P001364