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A Functional Magnetic Resonance Imaging (fMRI) Study of Expectancy on Acupuncture Treatment Outcomes in Knee Osteoarthritis (OA) - NCT01040754-02129(Clinical Trial 463831)



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City:  Charlestown
State:  
MA
Zip Code: 02129
Conditions: Osteoarthritis, Knee
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.
Study summary:
Criteria: Inclusion Criteria: - Volunteers 40-65 years of age. - Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the right knee for at least the past 3 months, as determined by the referring physician. - If patients have a diagnosis of bilateral OA, symptoms must be more intense in the right knee. - Radiographic evidence of Grade 2 or 3 knee OA using the Kellgren-Lawrence Scale. - Patients must have moderate or greater clinically significant pain on most days during the past month (more than 15 days out of 30, of average daily pain of >3/10). - Average pain intensity and level of function within the range of 3-7 on the WOMAC scale, a subset score of the KOOS. - 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: - Any interventional procedure for knee pain, including corticosteroid injections (within 2 months) to the knee. - 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. - Presence of any illness or medication use that is judged to interfere with the trial. For example: skin irritations around the knee such as psoriasis; bleeding disorders or anticoagulant use that would be contraindications for acupuncture - Knee pain due to other causes, such as inflammation or malignancy, other pain disorders that may refer pain to the leg, OA of ipsilateral hip, diagnosis of RA. - Non-ambulatory status. - 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 fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy. - Instability of pain rating within Session 1 or Session 2 of Experiment One or Visit 1 of Experiment Two.
Study is available at: Massachusetts General Hospital
Charlestown, MA 02129
United States

Primary Contact:
Rita Loiotile
Email: rloiotile@partners.org
Phone: 617-643-7947

Secondary Contact:
Rita Loiotile
Email: rloiotile@partners.org
Phone: 617-643-947
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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