Back to resultsfMRI Study of Expectancy on Acupuncture Treatment Outcomes in Knee OA (KOA)
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis, Knee
Eligibility 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Acupuncture
Waitlist Control
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01040754
First Posted
December 28, 2009
Last Updated
March 10, 2016
Sponsor
Massachusetts General Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01040754
Brief Title
fMRI Study of Expectancy on Acupuncture Treatment Outcomes in Knee OA
Acronym
KOA
Official Title
An fMRI Study of Expectancy on Acupuncture Treatment Outcomes in Knee OA
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Title
Waitlist Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy L Gollub, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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fMRI Study of Expectancy on Acupuncture Treatment Outcomes in Knee OA
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