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A Functional Magnetic Resonance Imaging (fMRI) Study of Expectancy on Acupuncture Treatment Outcomes in Knee Osteoarthritis (OA) (KOA)
This study is currently recruiting participants.
Verified April 2010 by Massachusetts General Hospital

First Received on December 28, 2009.   Last Updated on April 22, 2010   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The difference (pre- minus post-treatment) in subjective pain rating and fMRI BOLD response to calibrated experimental noxious stimuli (noxious heat and pressure) used as a proxy for endogenous knee pain. [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]

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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040754

Contacts
Contact: Rita Loiotile 617-643-947 rloiotile@partners.org
Contact: Carolyn Zyloney 617-643-7268 czyloney@partners.org

Locations
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    
Sponsors and Collaborators
Massachusetts General Hospital
Harvard University
Brigham and Women's Hospital
Investigators
Principal Investigator: Randy L Gollub, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012