Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Contact Information
Primary
Chenchen Wang, MD, MSc
Chenchen.Wang@tuftsmedicine.org
617-636-3251
Backup
Sherwood Alexis, MHA, MBA
sherwood.alexis@tuftsmedicalcenter.org
617-636-5405
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 480
Treatments
Experimental: 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.
No_intervention: 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).
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH), Boston Medical Center, The Cleveland Clinic, University of California, Los Angeles
Leads: Tufts Medical Center

This content was sourced from clinicaltrials.gov