Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
480 participants
INTERVENTIONAL
2025-04-07
2028-08-31
Brief Summary
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* Compared to routine care, will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain (WOMAC pain score, primary outcome), pain interference (PROMIS-Pain Interference, secondary outcome), and health-related quality of life at 3 months?
* Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period?
Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tai Chi + Routine Care
The intervention will be delivered via a HIPAA-secure web-based video platform. All remote Tai Chi sessions will be 60 minutes, twice a week, for 3 months. All program components will use the Yang style Tai Chi, and every session will include warm up, review of principles, meditation with movement, breathing techniques and relaxation.
Remote Tai Chi
Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.
Routine Care
Participants will be encouraged to continue their ongoing care for Knee OA by their providers. In addition, primary care providers and other participating clinicians in the health system will receive information from the study team on routine care or "2019 ACR Guideline-Based Care." At the end of the 12-month trial period, routine care participants will be offered access to recordings for the full 3-month Tai Chi program (24 sessions).
No interventions assigned to this group
Interventions
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Remote Tai Chi
Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.
Eligibility Criteria
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Inclusion Criteria
* Treating clinician diagnosis of knee osteoarthritis
* Have a score of 40 (visual analog version) or greater on at least 1 of the 5 questions in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range of 0 to 100, with higher scores indicating greater pain) at baseline.
* Able to provide informed consent
* If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study
* If randomized to the Tai Chi group, willing to comply with the Tai Chi program (twice-a-week remote sessions for 12 weeks)
* Has access to a home computer or device that will allow telehealth (bidirectional audio and video) delivery of the intervention
* Is an active patient at one of the 4 participating healthcare system
Exclusion Criteria
* Serious medical conditions (e.g., dementia, significant neurological deficits or neurodegenerative disorder, active cancer treatment, psychosis, sensory deficits) limiting the participant's ability to participate in the Tai Chi safely, as determined by the principal investigators
* Unable to walk without a cane or other assistive device
* Any previous or scheduled knee replacement
* Reports severe depression defined by a Beck Depression Inventory (BDI-II) score of 29 or more.
* Reports suicidal ideations defined by a score on BDI-II item of 2 or 3 ('I would like to kill myself' or 'I would kill myself if I had the chance').
* Not English speaking
* Enrollment in any other clinical trial within the last 30 days
50 Years
100 Years
ALL
No
Sponsors
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Boston Medical Center
OTHER
University of California, Los Angeles
OTHER
The Cleveland Clinic
OTHER
National Center for Complementary and Integrative Health (NCCIH)
NIH
Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Chenchen Wang, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Robert Saper, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Eric Roseen, DC, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Helen Lavetrsky, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Study website
Other Identifiers
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STUDY00002259
Identifier Type: -
Identifier Source: org_study_id
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