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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) Harvard University Brigham and Women's Hospital |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01040754 |
Purpose
The results of the proposed experiments will directly inform clinicians who treat patients with osteoarthritis of the knee about how to maximize the benefits of acupuncture treatments. And because the experiments specifically asks the question of what is the relation between a patient's expectation of how a treatment will relieve their pain and the outcome of the treatment, the results will potentially inform care givers about all treatments for osteoarthritis and other chronic pain disorders. We hypothesize that acupuncture treatment will produce clinically significant analgesia as indicated by lowered sensory ratings of noxious stimuli and endogenous knee pain.
| Condition | Intervention |
|---|---|
|
Osteoarthritis, Knee |
Other: Acupuncture |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An fMRI Study of Expectancy on Acupuncture Treatment Outcomes in Knee OA |
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Acupuncture |
Other: Acupuncture
This study employs Berman's standardized acupuncture protocol for OA knee pain. Approximately 8 to 9 acupuncture needles are placed in the skin of the leg for 20 minutes and electro-acupuncture stimulation will be applied during this time.
Other Name: Acupuncture
|
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rita Loiotile | 617-643-947 | rloiotile@partners.org |
| Contact: Carolyn Zyloney | 617-643-7268 | czyloney@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Charlestown, Massachusetts, United States, 02129 | |
| Contact: Rita Loiotile 617-643-7947 rloiotile@partners.org | |
| Contact: Carolyn Zyloney 617-643-7268 czyloney@gmail.com | |
| Principal Investigator: | Randy L Gollub, MD, PhD | Massachusetts General Hospital |
More Information
| Responsible Party: | Randy L. Gollub, M.D., Ph.D., Associate Professor, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01040754 History of Changes |
| Other Study ID Numbers: | 2009P000096, 2P01AT002048-06 |
| Study First Received: | December 28, 2009 |
| Last Updated: | April 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |