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Clinical Trial NCT06384898 (TAICHIKNEE) for Knee Osteoarthritis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Remote Tai Chi for Knee Osteoarthritis (TAICHIKNEE)

Recruiting
Clinical Trial NCT06384898 (TAICHIKNEE) is an interventional study for Knee Osteoarthritis that is recruiting. It started on April 7, 2025 with plans to enroll 480 participants. Led by Tufts Medical Center, it is expected to complete by August 31, 2028. The latest data from ClinicalTrials.gov was last updated on July 8, 2025.
Brief Summary
The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:

  • 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.

Detailed Description
Investigators will conduct a 12-month embedded, pragmatic, hybrid type 1 effectiveness-implementation, individually randomized group-treatment trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention plus routine care versus routine care alone across four health care systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, and Cleveland Clinic) in four geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio (Cleveland Clinic), Southern Florida (Cleveland Clinic). Investigators will enroll a total of 480 diverse patients with a clinical diagnosis of Knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months.
Official Title

Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial

Conditions
Knee Osteoarthritis
Other Study IDs
NCT ID Number
NCT06384898
Start Date (Actual)
2025-04-07
Last Update Posted
2025-07-08
Completion Date (Estimated)
2028-08-31
Enrollment (Estimated)
480
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Pragmatic Clinical Trial
Implementation Science
Mind-body Therapies
Tai Chi
Knee Osteoarthritis
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTai 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.
No InterventionRoutine 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).
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.
3 months from randomization
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
PROMIS Pain Interference score
The PROMIS Pain Interference short form 6b evaluates the extent to which pain interferes with physical, emotional and social activities. The raw score ranges between 6-30 and the T score ranges between 41.0-78.3, with higher scores indicating that pain has a greater negative impact.
3 months from randomization
SF-12 PCS score
The 12-item Short Form Health Survey (SF-12) has two summary scales, the Mental Health Component Score (MCS) and the Physical Component Score (PCS). Both scores range from 0 to 100, with higher scores indicating better mental and physical health.
3 months from randomization
Number of knee joint injections
Total number of intra-articular injections identified through EHR and patient questionnaires.
12 months from randomization
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
All
  • Age 50 years or older
  • 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

  • Currently practicing Tai Chi
  • 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
Tufts Medical Center logoTufts Medical Center
  • ⚕️Boston Medical Center
  • University of California, Los Angeles logoUniversity of California, Los Angeles339 active trials to explore
  • 🏥The Cleveland Clinic
  • ⚕️National Center for Complementary and Integrative Health (NCCIH)
Study Central Contact
Contact: Chenchen Wang, MD, MSc, 617-636-3251, [email protected]
Contact: Sherwood Alexis, MHA, MBA, 617-636-5405, [email protected]
1 Study Locations in 1 Countries

Massachusetts

Tufts Medical Center, Boston, Massachusetts, 02111, United States
Sherwood Alexis, MHA, MBA, Contact, 617-636-5405, [email protected]
Chenchen Wang, MD, Principal Investigator
William Harvey, MD, Sub-Investigator
Recruiting