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

May 11, 2012
April 2, 2014
January 2012
September 2016   (final data collection date for primary outcome measure)
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.
Back pain severity assessment will be used to determine the effects of acupuncture for Lower Back Pain. [ Time Frame: Six Weeks ] [ Designated as safety issue: No ]
Low back pain severity rating, cerebral blood flow (CBF) changes as measured by arterial spin labeling (ASL)
Complete list of historical versions of study NCT01598974 on ClinicalTrials.gov Archive Site
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Back Pain Response to Different Acupuncture Methods
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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Lower Back Pain
  • Procedure: Traditional Acupuncture
  • Procedure: Laser Acupuncture
  • Experimental: Traditional Acupuncture
    Participants will receive acupuncture over 6 30-minute sessions.
    Intervention: Procedure: Traditional Acupuncture
  • Experimental: Laser Acupuncture
    Participants will receive laser acupuncture over 6 30-minute sessions.
    Intervention: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
129
December 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
United States
 
NCT01598974
2011P001364
Yes
Robert Edwards, Brigham and Women's Hospital
Brigham and Women's Hospital
  • Massachusetts General Hospital
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Robert R Edwards, Ph.D. Brigham and Women's Hospital
Brigham and Women's Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP