CClinicalTrials.gg
RecruitingNCT06384898TAICHIKNEEUpdated Sep 4, 2026

Remote Tai Chi for Knee Osteoarthritis

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

Phase
Not applicable
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
50 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Pragmatic Clinical Trial
  • Implementation Science
  • Mind-body Therapies
  • Tai Chi
  • Knee Osteoarthritis
03

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
480 participants (estimated)

Study arms

  • 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.

    Other: Remote Tai Chi

  • 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).

Interventions

  • OtherRemote Tai Chi

    Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Number of knee joint injections

    Total number of intra-articular injections identified through EHR and patient questionnaires.

    Time frame: 12 months from randomization

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. Patient's global assessment score

    VAS 0-100

    Time frame: 3 months from randomization

  20. Patient's global assessment score

    VAS 0-100

    Time frame: 6 months from randomization

  21. Patient's global assessment score

    VAS 0-100

    Time frame: 12 months from randomization

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. SF-12 MCS score

    The SF-12 Mental Component Score ranges between 0-100.

    Time frame: 3 months from randomization

  29. SF-12 MCS score

    The SF-12 Mental Component Score ranges between 0-100.

    Time frame: 6 months from randomization

  30. SF-12 MCS score

    The SF-12 Mental Component Score ranges between 0-100.

    Time frame: 12 months from randomization

  31. OMERACT/OARSI responder

    Number of participants who meet the OMERACT/OARSI responder criteria

    Time frame: 3 months from randomization

  32. OMERACT/OARSI responder

    Number of participants who meet the OMERACT/OARSI responder criteria

    Time frame: 6 months from randomization

  33. OMERACT/OARSI responder

    Number of participants who meet the OMERACT/OARSI responder criteria

    Time frame: 12 months from randomization

  34. Receipt of knee surgery

    Number of Participants who receive knee surgery.

    Time frame: 12 months from randomization

  35. Pain medication use

    Time frame: 3 months from randomization

  36. Pain medication use

    Time frame: 6 months from randomization

  37. Pain medication use

    Time frame: 12 months from randomization

06

Study locations

1 of 1 sites recruiting
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
    Recruiting
07

References and documents

Related links

Individual participant data

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

08

Registry details

Key details

Study ID
NCT06384898
Lead sponsor
Tufts Medical Center
Collaborators
Boston Medical Center, University of California, Los Angeles, The Cleveland Clinic, National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Sponsor
First posted
Apr 25, 2024
Start date
Apr 7, 2025
Primary completion
Mar 5, 2027 (estimated)
Completion
Dec 10, 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Chenchen Wang, MD, MSc
Contact
Chenchen.Wang@tuftsmedicine.org
617-636-3251
Sherwood Alexis, MHA, MBA
Contact
sherwood.alexis@tuftsmedicalcenter.org
617-636-2612
Chenchen Wang, MD, MSc
principal investigator · Tufts Medical Center
Robert Saper, MD, MPH
principal investigator · The Cleveland Clinic
Eric Roseen, DC, PhD
principal investigator · Boston Medical Center
Helen Lavetrsky, MD, MS
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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