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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01040754

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH), Beth Israel Deaconess Medical Center (Other), Brigham and Women's Hospital (Other)

144

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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	Phase
Osteoarthritis, Knee	Other: Acupuncture	N/A

Study Design

Study Type:

Interventional

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 :

Jun 1, 2009

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Feb 1, 2016

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

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

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. [6-8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Randy L. Gollub, Clinical Associate at Massachusetts General Hospital, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01040754

Other Study ID Numbers:

2009P000096
R01AT005280

First Posted:

Dec 30, 2009

Last Update Posted:

Mar 14, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Osteoarthritis, Knee

Study Results

No Results Posted as of Mar 14, 2016