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NCT Number: NCT06384898

Remote Tai Chi for Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location status: Recruiting

Location contact

Chenchen Wang, MD

PRINCIPAL_INVESTIGATOR

Sherwood Alexis, MHA, MBA

CONTACT

[email protected]

617-636-5405

William Harvey, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Remote Tai Chi

Other

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

Primary outcomes

  1. WOMAC Pain Score

    Time frame: 3 months from randomization

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.

Secondary outcomes

  1. PROMIS Pain Interference score

    Time frame: 3 months from randomization

    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.

  2. SF-12 PCS score

    Time frame: 3 months from randomization

    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. Number of knee joint injections

    Time frame: 12 months from randomization

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

Other outcomes

  1. WOMAC Pain Score

    Time frame: 6 months from randomization

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.

  2. WOMAC Pain Score

    Time frame: 12 months from randomization

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.

  3. PROMIS Pain Interference score

    Time frame: 6 months from randomization

    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.

  4. PROMIS Pain Interference score

    Time frame: 12 months from randomization

    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.

  5. SF-12 PCS score

    Time frame: 6 months from randomization

    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.

  6. SF-12 PCS score

    Time frame: 12 months from randomization

    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.

  7. WOMAC total score

    Time frame: 3 months from randomization

    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.

  8. WOMAC total score

    Time frame: 6 months from randomization

    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.

  9. WOMAC total score

    Time frame: 12 months from randomization

    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.

  10. WOMAC Pain Score on nominated activity chosen at baseline

    Time frame: 3 months from randomization

    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?)

  11. WOMAC Pain Score on nominated activity chosen at baseline

    Time frame: 6 months from randomization

    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?)

  12. WOMAC Pain Score on nominated activity chosen at baseline

    Time frame: 12 months from randomization

    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?)

  13. WOMAC function score

    Time frame: 3 months from randomization

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score rated on a Visual Analog Scale (VAS) of 0-100 mm.

  14. WOMAC function score

    Time frame: 6 months from randomization

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score rated on a Visual Analog Scale (VAS) of 0-100 mm.

  15. WOMAC function score

    Time frame: 12 months from randomization

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score rated on a Visual Analog Scale (VAS) of 0-100 mm.

  16. WOMAC stiffness score

    Time frame: 3 months from randomization

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score rated on a Visual Analog Scale (VAS) of 0-100 mm.

  17. WOMAC stiffness score

    Time frame: 6 months from randomization

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score rated on a Visual Analog Scale (VAS) of 0-100 mm.

  18. WOMAC stiffness score

    Time frame: 12 months from randomization

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score rated on a Visual Analog Scale (VAS) of 0-100 mm.

  19. Patient's global assessment score

    Time frame: 3 months from randomization

    VAS 0-100

  20. Patient's global assessment score

    Time frame: 6 months from randomization

    VAS 0-100

  21. Patient's global assessment score

    Time frame: 12 months from randomization

    VAS 0-100

  22. PROMIS sleep disturbance OA Knee- Short Form 6a

    Time frame: 3 months from randomization

    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.

  23. PROMIS sleep disturbance OA Knee- Short Form 6a

    Time frame: 6 months from randomization

    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.

  24. PROMIS sleep disturbance OA Knee- Short Form 6a

    Time frame: 12 months from randomization

    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.

  25. Beck Depression Inventory-II score

    Time frame: 3 months from randomization

    The Beck Depression Inventory-II score ranges between 0-63, with higher scores indicating more severe depression symptoms.

  26. Beck Depression Inventory-II score

    Time frame: 6 months from randomization

    The Beck Depression Inventory-II score ranges between 0-63, with higher scores indicating more severe depression symptoms.

  27. Beck Depression Inventory-II score

    Time frame: 12 months from randomization

    The Beck Depression Inventory-II score ranges between 0-63, with higher scores indicating more severe depression symptoms.

  28. SF-12 MCS score

    Time frame: 3 months from randomization

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

  29. SF-12 MCS score

    Time frame: 6 months from randomization

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

  30. SF-12 MCS score

    Time frame: 12 months from randomization

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

  31. OMERACT/OARSI responder

    Time frame: 3 months from randomization

    Number of participants who meet the OMERACT/OARSI responder criteria

  32. OMERACT/OARSI responder

    Time frame: 6 months from randomization

    Number of participants who meet the OMERACT/OARSI responder criteria

  33. OMERACT/OARSI responder

    Time frame: 12 months from randomization

    Number of participants who meet the OMERACT/OARSI responder criteria

  34. Receipt of knee surgery

    Time frame: 12 months from randomization

    Number of Participants who receive knee surgery.

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Chenchen Wang, MD, MSc

CONTACT

[email protected]

617-636-3251

Sherwood Alexis, MHA, MBA

CONTACT

[email protected]

617-636-5405

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Boston Medical Center
  • National Center for Complementary and Integrative Health (NCCIH)
  • The Cleveland Clinic
  • University of California, Los Angeles

Registry information

Official study title

Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial

Acronym: TAICHIKNEE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2024
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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