Back Pain Response to Different Acupuncture Methods (LBP)
This study is currently recruiting participants.
Verified April 2013 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01598974
First received: May 11, 2012
Last updated: April 22, 2013
Last verified: April 2013
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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 (criteria recommended by Dworkin et al. [72]).
- Patients must be able to provoke or exacerbate their cLBP 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
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: | Ajay D Wasan, M.D | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | Ajay D. Wasan,M.D.,M.Sc., 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 22, 2013 |
| 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 May 23, 2013