An interventional study of Remote Tai Chi in Knee Osteoarthritis, sponsored by Tufts Medical Center. Recruiting at 1 site in United States. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Tufts Medical Center · Not applicable, Interventional, and Treatment
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:
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.
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.
Exclusion Criteria:
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.
Other: Remote Tai Chi
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).
Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.
WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 3 months from randomization
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.
Time frame: 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.
Time frame: 3 months from randomization
Number of knee joint injections
Total number of intra-articular injections identified through EHR and patient questionnaires.
Time frame: 12 months from randomization
WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 6 months from randomization
WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 12 months from randomization
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.
Time frame: 6 months from randomization
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.
Time frame: 12 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.
Time frame: 6 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.
Time frame: 12 months from randomization
WOMAC total score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score calculated by summing the pain, stiffness, and physical function subscales, rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 3 months from randomization
WOMAC total score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score calculated by summing the pain, stiffness, and physical function subscales, rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 6 months from randomization
WOMAC total score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score calculated by summing the pain, stiffness, and physical function subscales, rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 12 months from randomization
WOMAC Pain Score on nominated activity chosen at baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.(Considering ALL the ways Knee PAIN affects participants, which activity is most important to participants today?)
Time frame: 3 months from randomization
WOMAC Pain Score on nominated activity chosen at baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.(Considering ALL the ways Knee PAIN affects participants, which activity is most important to participants today?)
Time frame: 6 months from randomization
WOMAC Pain Score on nominated activity chosen at baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.(Considering ALL the ways Knee PAIN affects participants, which activity is most important to participants today?)
Time frame: 12 months from randomization
WOMAC function score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 3 months from randomization
WOMAC function score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 6 months from randomization
WOMAC function score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 12 months from randomization
WOMAC stiffness score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 3 months from randomization
WOMAC stiffness score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 6 months from randomization
WOMAC stiffness score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame: 12 months from randomization
Patient's global assessment score
VAS 0-100
Time frame: 3 months from randomization
Patient's global assessment score
VAS 0-100
Time frame: 6 months from randomization
Patient's global assessment score
VAS 0-100
Time frame: 12 months from randomization
PROMIS sleep disturbance OA Knee- Short Form 6a
PROMIS sleep disturbance OA knee raw score ranges between 6-30 and the T score ranges between 29.8-76.1, with higher scores indicates greater sleep disturbance.
Time frame: 3 months from randomization
PROMIS sleep disturbance OA Knee- Short Form 6a
PROMIS sleep disturbance OA knee raw score ranges between 6-30 and the T score ranges between 29.8-76.1, with higher scores indicates greater sleep disturbance.
Time frame: 6 months from randomization
PROMIS sleep disturbance OA Knee- Short Form 6a
PROMIS sleep disturbance OA knee raw score ranges between 6-30 and the T score ranges between 29.8-76.1, with higher scores indicates greater sleep disturbance.
Time frame: 12 months from randomization
Beck Depression Inventory-II score
The Beck Depression Inventory-II score ranges between 0-63, with higher scores indicating more severe depression symptoms.
Time frame: 3 months from randomization
Beck Depression Inventory-II score
The Beck Depression Inventory-II score ranges between 0-63, with higher scores indicating more severe depression symptoms.
Time frame: 6 months from randomization
Beck Depression Inventory-II score
The Beck Depression Inventory-II score ranges between 0-63, with higher scores indicating more severe depression symptoms.
Time frame: 12 months from randomization
SF-12 MCS score
The SF-12 Mental Component Score ranges between 0-100.
Time frame: 3 months from randomization
SF-12 MCS score
The SF-12 Mental Component Score ranges between 0-100.
Time frame: 6 months from randomization
SF-12 MCS score
The SF-12 Mental Component Score ranges between 0-100.
Time frame: 12 months from randomization
OMERACT/OARSI responder
Number of participants who meet the OMERACT/OARSI responder criteria
Time frame: 3 months from randomization
OMERACT/OARSI responder
Number of participants who meet the OMERACT/OARSI responder criteria
Time frame: 6 months from randomization
OMERACT/OARSI responder
Number of participants who meet the OMERACT/OARSI responder criteria
Time frame: 12 months from randomization
Receipt of knee surgery
Number of Participants who receive knee surgery.
Time frame: 12 months from randomization
Pain medication use
Time frame: 3 months from randomization
Pain medication use
Time frame: 6 months from randomization
Pain medication use
Time frame: 12 months from randomization
Plan to share: Yes — This study will submit and share de-identified individual patient data as described in our Data Management and Sharing Plan and will follow NIH policies for data sharing
Supporting information: Study protocol, Sap
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