TAICHIKNEE trial: protocol for an embedded pragmatic, individually randomised group-treatment trial of remotely delivered Tai Chi for knee osteoarthritis across US healthcare systems
13 affiliations
- 1Center for Integrative Medicine and Division of Rheumatology, Allergy & Immunology, Tufts Medicine/ Tufts Medical Center, Boston, Massachusetts, USA
- 2Nancy J. and Michael F. Roizen Chair of Wellness, Cleveland Clinic, Cleveland, Ohio, USA
- 3Section of General Internal Medicine/ Department of Medicine, Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center, Boston, Massachusetts, USA
- 4Department of Psychiatry and Biobehavioral Sciences/Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, California, USA
- 5Musculoskeletal Research Program/ Rheumatology, UMass Chan Medical School/ UMass Memorial Health, Worcester, Massachusetts, USA
- 6Division of General Internal Medicine & Health Services Research/ Department of Medicine, David Geffen School of Medicine/ University of California Los Angeles, Los Angeles, California, USA
- 7Department of Family Medicine, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA
- 8Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, California, USA
- 9The Office of Clinical and Regulatory Affairs, National Center for Complementary and Integrative Health, Bethesda, Maryland, USA
- 10Center for Mind-Body Therapies, Boston, Massachusetts, USA
- 11Department of Family and Community Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA
- 12Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA
- 13Tufts University Clinical and Translational Science Institute, Boston, Massachusetts, USA
Abstract
Introduction Symptomatic knee osteoarthritis (OA) is a leading cause of chronic pain and disability and is associated with substantial healthcare utilisation and costs. In-person Tai Chi, a multidimensional mind-body exercise, is recommended as a non-pharmacological therapy for knee OA; however, delivery through in-person classes may limit scalability across US healthcare systems. Remote delivery may reduce logistical barriers and facilitate integration into routine care, but evidence regarding its effectiveness and implementation in real-world healthcare settings remains limited. We describe the protocol for TAICHIKNEE, an embedded pragmatic trial evaluating remotely delivered group Tai Chi plus routine care vs routine care alone for adults with symptomatic knee OA.Methods and analysis TAICHIKNEE is a 12-month, fully decentralised, embedded pragmatic, individually randomised group-treatment trial with an effectiveness-implementation hybrid type 1 design conducted across five US healthcare systems. The trial will randomise 480 adults aged ≥50 years with symptomatic, clinician-diagnosed knee OA in a 1:1 ratio within six sequential cohorts, stratified by healthcare system and sex. Participants assigned to Tai Chi will receive 24 live, instructor-led 60-minute videoconference sessions over 12 weeks in addition to routine care; control participants will continue routine care. The cohort randomisation date defines time zero for both groups. The primary outcome is Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain at 3 months, analysed using a partially nested mixed-effects model that accounts for clustering within Tai Chi classes and adjusts for baseline WOMAC pain and prespecified covariates. Key secondary outcomes are Patient-Reported Outcomes Measurement Information System Pain Interference and SF-12 health-related quality of life scores at 3 months, and knee joint injections over 12 months. Safety will be assessed throughout the 12-month follow-up. The implementation evaluation will concurrently assess intervention fidelity, stakeholder perspectives and participant and instructor experiences using Consolidated Framework for Implementation Research-informed stakeholder interviews, fidelity assessments and surveys to identify factors influencing implementation and inform future sustainment and spread across healthcare systems.Ethics and dissemination Ethical approval was obtained from the Tufts University Health Sciences Institutional Review Board (IRB) (STUDY00003780), serving as the single IRB of record for all participating sites. Results will be disseminated through peer-reviewed publications, conferences and stakeholder engagement activities across healthcare systems. De-identified participant-level data and study materials will be shared in accordance with applicable data-sharing policies, participant consent, IRB requirements and the approved data-sharing plan.Trial registration number NCT06384898.
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BibTeX
@article{wang2026taichiknee,
title = {{TAICHIKNEE trial: protocol for an embedded pragmatic, individually randomised group-treatment trial of remotely delivered Tai Chi for knee osteoarthritis across US healthcare systems}},
author = {Chenchen Wang and Robert B Saper and Eric Roseen and Helen Lavretsky and Timothy McAlindon and William Harvey and Weijun Zhang and Lance Laird and Brian Mittman and Qilu Yu and Emily Hurstak and Sherwood Alexis and Ramel Rones and Pilar Margaret Sanjuan and Andrew L Sussman and Ludovic Trinquart},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-127972},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-127972},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - TAICHIKNEE trial: protocol for an embedded pragmatic, individually randomised group-treatment trial of remotely delivered Tai Chi for knee osteoarthritis across US healthcare systems
AU - Chenchen Wang
AU - Robert B Saper
AU - Eric Roseen
AU - Helen Lavretsky
AU - Timothy McAlindon
AU - William Harvey
AU - Weijun Zhang
AU - Lance Laird
AU - Brian Mittman
AU - Qilu Yu
AU - Emily Hurstak
AU - Sherwood Alexis
AU - Ramel Rones
AU - Pilar Margaret Sanjuan
AU - Andrew L Sussman
AU - Ludovic Trinquart
PY - 2026
DA - 2026/10/23
JO - BMJ Open
DO - 10.1136/bmjopen-2026-127972
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-127972
AB - Introduction Symptomatic knee osteoarthritis (OA) is a leading cause of chronic pain and disability and is associated with substantial healthcare utilisation and costs. In-person Tai Chi, a multidimensional mind-body exercise, is recommended as a non-pharmacological therapy for knee OA; however, delivery through in-person classes may limit scalability across US healthcare systems. Remote delivery may reduce logistical barriers and facilitate integration into routine care, but evidence regarding its effectiveness and implementation in real-world healthcare settings remains limited. We describe the protocol for TAICHIKNEE, an embedded pragmatic trial evaluating remotely delivered group Tai Chi plus routine care vs routine care alone for adults with symptomatic knee OA.Methods and analysis TAICHIKNEE is a 12-month, fully decentralised, embedded pragmatic, individually randomised group-treatment trial with an effectiveness-implementation hybrid type 1 design conducted across five US healthcare systems. The trial will randomise 480 adults aged ≥50 years with symptomatic, clinician-diagnosed knee OA in a 1:1 ratio within six sequential cohorts, stratified by healthcare system and sex. Participants assigned to Tai Chi will receive 24 live, instructor-led 60-minute videoconference sessions over 12 weeks in addition to routine care; control participants will continue routine care. The cohort randomisation date defines time zero for both groups. The primary outcome is Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain at 3 months, analysed using a partially nested mixed-effects model that accounts for clustering within Tai Chi classes and adjusts for baseline WOMAC pain and prespecified covariates. Key secondary outcomes are Patient-Reported Outcomes Measurement Information System Pain Interference and SF-12 health-related quality of life scores at 3 months, and knee joint injections over 12 months. Safety will be assessed throughout the 12-month follow-up. The implementation evaluation will concurrently assess intervention fidelity, stakeholder perspectives and participant and instructor experiences using Consolidated Framework for Implementation Research-informed stakeholder interviews, fidelity assessments and surveys to identify factors influencing implementation and inform future sustainment and spread across healthcare systems.Ethics and dissemination Ethical approval was obtained from the Tufts University Health Sciences Institutional Review Board (IRB) (STUDY00003780), serving as the single IRB of record for all participating sites. Results will be disseminated through peer-reviewed publications, conferences and stakeholder engagement activities across healthcare systems. De-identified participant-level data and study materials will be shared in accordance with applicable data-sharing policies, participant consent, IRB requirements and the approved data-sharing plan.Trial registration number NCT06384898.
SN - 2044-6055
SN - 2044-6055
ER -