A Functional Magnetic Resonance Imaging (fMRI) Study of Expectancy on Acupuncture Treatment Outcomes in Knee Osteoarthritis (OA) (KOA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Massachusetts General Hospital
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Randy L. Gollub, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01040754
First received: December 28, 2009
Last updated: March 20, 2013
Last verified: March 2013
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
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
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.
Other Name: Acupuncture
No Intervention: Waitlist Control

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Rosa Spaeth 617-643-7947 rspaeth1@partners.org
Contact: Sonya Freeman 617-643-7268 sfreeman3@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Rosa Spaeth    617-643-7947    rspaeth1@partners.org   
Contact: Sonya Freeman    617-643-7268    sfreeman3@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
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, Clinical Associate at Massachusetts General Hospital, 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: March 20, 2013
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 September 18, 2014