Comparative effectiveness of Tai Chi, Baduanjin, and health education for knee osteoarthritis: protocol of a three-arm randomized controlled trial.

BACKGROUND

Knee osteoarthritis (OA) is a leading cause of chronic pain and disability. With projections indicating 642 million affected individuals globally by 2050, identifying safe, scalable, and potentially disease-modifying non-pharmacological interventions is an urgent public health priority. This study aims to compare the clinical effectiveness of Tai Chi, Baduanjin, and a health-education programme in preserving joint function and quality of life for patients with knee OA.

METHODS/

DESIGN

A single-centre, 48-week, comparative-effectiveness randomised controlled trial comparing Tai Chi, Baduanjin and health-education programme will be conducted at Zhongshan Hospital of Traditional Chinese Medicine. Eligible participants consists of adults ≥60 years of age with symptomatic and radiographic knee OA. Participants will be randomly assigned (1:1:1) using a computer-generated randomization sequence to one of three groups: (1) Tai Chi training, 5 sessions per week (60 min each) for 12 weeks; (2) Baduanjin training, 5 sessions per week (60 min each) for 12 weeks; or (3) health-education, 1 session per week (60 min each) for 12 weeks. Outcome assessors will be blinded to group allocation. The primary outcomes are the pain, stiffness and physical function subscales of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes include the Berg Balance Scale, 6 min walk test and SF-36 quality-of-life assessment. All measures will be assessed at weeks 12, 24 and 48.

DISCUSSION: By comparing two traditional mind-body exercises against an active control group over 48 weeks, this trial is designed to determine whether these interventions offer durable clinical benefits as standalone therapies or provide additive value. The findings are expected to provide high-quality evidence regarding scalable, low-cost non-pharmacologic strategies for managing knee OA, with potential implications for public health policy.

CLINICAL TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry (ITMCTR), http://itmctr.ccebtcm.org.cn/, identifier ITMCTR2025000409.