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fMRI Study of Expectancy on Acupuncture Treatment Outcomes in Knee OA (KOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01040754
Recruitment Status : Completed
First Posted : December 30, 2009
Last Update Posted : March 14, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Osteoarthritis, Knee Other: Acupuncture

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: An fMRI Study of Expectancy on Acupuncture Treatment Outcomes in Knee OA
Study Start Date : June 2009
Primary Completion Date : October 2015
Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Acupuncture Other: Acupuncture
This study follows a standardized acupuncture protocol for OA knee pain. Approximately 6 acupuncture needles are placed in the skin of the leg for 25 minutes.
No Intervention: Waitlist Control


Outcome Measures

Primary Outcome Measures :
  1. 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: 6-8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Volunteers 40-70 years of age.
  • Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months, as determined by the referring physician.
  • Radiographic evidence of Grade 2 or 3 knee OA using the Kellgren-Lawrence Scale.
  • Ability to read and understand English; 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; diabetes due to the increased possibility of sensitivity to heat pain; and use of opiate medications and other substances of abuse that may influence the patient's experience of analgesia. (Due to the potential risk that prescription or non-prescription medication use can confound our results, we may perform a urine toxicology screen to verify patient's medication status during Session 1.)
  • 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 rheumatoid arthritis (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040754


Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Investigators
Principal Investigator: Randy L Gollub, MD, PhD Massachusetts General Hospital
More Information

Responsible Party: Randy L. Gollub, Clinical Associate at Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01040754     History of Changes
Other Study ID Numbers: 2009P000096
R01AT005280 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2009    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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