Back Pain Response to Different Acupuncture Methods (LBP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Brigham and Women's Hospital
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01598974
First received: May 11, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Lower Back Pain
Procedure: Traditional Acupuncture
Procedure: Laser Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Brain Plasticity Underlying Back Pain Response to Different Acupuncture Methods

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Pain improvement in patients with lower back pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Pain rating changes for chronic low back pain after acupuncture sessions.


Estimated Enrollment: 129
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 any condition. Because we are using a placebo needle as a control, acupuncture-naive patients are necessary to maximize the benefits of blinding and to control expectancy.
  • 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 prescription opioids or steroids for pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598974

Locations
United States, Massachusetts
MGH - Martinos Center Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Andrew J Dolman, MA    617-726-0324    adolman@partners.org   
Principal Investigator: Ajay D Wasan, M.D         
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Robert R Edwards, Ph.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Robert Edwards, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01598974     History of Changes
Other Study ID Numbers: 2011P001364
Study First Received: May 11, 2012
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Lower Back Pain
Acupuncture

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

ClinicalTrials.gov processed this record on July 23, 2014