Brain Imaging Study of Acupuncture in Chronic Low Back Pain
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:
NCT01614639
First received: May 23, 2012
Last updated: April 22, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
We are doing this research study to learn about how acupuncture treatment works. This study is being done to look at changes in the brain, NOT to treat pain. We want to learn about brain activity during acupuncture. We will look at brain activity when a heating device touches the skin of a subject before and after the subject has acupuncture, to see what changes.
| Condition | Intervention |
|---|---|
|
Low Back Pain Back Pain Lower Back Chronic Low Back Pain, Recurrent |
Procedure: Acupuncture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients. |
Resource links provided by NLM:
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- Brain changes to acupuncture [ Time Frame: 3 visits ] [ Designated as safety issue: No ]The effects of pain on the brain
| Estimated Enrollment: | 138 |
| 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
Traditional Acupuncture given at 2 visits.
|
Procedure: Acupuncture
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
|
|
Experimental: Electroacupuncture
Electro-acupuncture given at 2 visits.
|
Procedure: Acupuncture
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Meet the Classification Criteria of 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 10-point LBP intensity 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
- 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 the subject's medical record
Exclusion Criteria:
- Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)
- Radicular pain extending below the knee
- 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 treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis)
- Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator and/or a T score > 60 on the psychological measures assessed during Session 1)
- 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.
- Active substance abuse disorder in the past two years, as determined by subject self-report
- The intent to undergo surgery during the time of involvement in the study
- History of cardiac, respiratory, or nervous system disease that, in the investigator'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
- Unresolved legal/disability/workers compensation claims in connection with low back.
- Instability of pain ratings in Session 2 or Session 3
- Use of prescription opioids or steroids for pain
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614639
Locations
| United States, Massachusetts | |
| MGH - Martinos Center | Recruiting |
| Charlestown, Massachusetts, United States, 02129 | |
| Contact: Andrew Dolman, MA 617-726-0324 | |
| Principal Investigator: Ajay D Wasan, M.D | |
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
| Principal Investigator: | Ajay Wasan, M.D | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | Ajay D. Wasan,M.D.,M.Sc., Investigator, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01614639 History of Changes |
| Other Study ID Numbers: | 2011P000748, P01AT006663-01 |
| Study First Received: | May 23, 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:
|
Acupuncture fMRI CLBP |
Pain Low Back Pain Back Pain |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013