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CompletedNCT01040754KOAUpdated Mar 14, 2016

fMRI Study of Expectancy on Acupuncture Treatment Outcomes in Knee OA

An interventional study of Acupuncture in Osteoarthritis, Knee, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-14.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Osteoarthritis, Knee
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In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 144 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
144 participants (actual)

Study arms

  • Active comparator
    Acupuncture

    Other: Acupuncture

  • No intervention
    Waitlist Control

Interventions

  • OtherAcupuncture

    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.

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What researchers measure

Primary outcomes

  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

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Study locations

1 site
  • Massachusetts General Hospital
    Charlestown, Massachusetts 02129, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01040754
Lead sponsor
Massachusetts General Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
Responsible party
Randy L. Gollub (Clinical Associate at Massachusetts General Hospital, Massachusetts General Hospital) — Principal investigator
First posted
Dec 30, 2009
Start date
Jun 2009
Primary completion
Oct 2015
Completion
Feb 2016
Last update
Mar 14, 2016

Study contacts

Randy L Gollub, MD, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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