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

This study has been completed.
National Center for Complementary and Integrative Health (NCCIH)
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Randy L. Gollub, Massachusetts General Hospital Identifier:
First received: December 28, 2009
Last updated: March 10, 2016
Last verified: March 2016
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: 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

Resource links provided by NLM:

Further study details as provided by Randy L. Gollub, 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: 6-8 weeks ]

Enrollment: 144
Study Start Date: June 2009
Study Completion Date: February 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
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Please refer to this study by its identifier: NCT01040754

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
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 Identifier: NCT01040754     History of Changes
Other Study ID Numbers: 2009P000096
R01AT005280 ( U.S. NIH Grant/Contract )
Study First Received: December 28, 2009
Last Updated: March 10, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on September 21, 2017