Mind-body exercises for mild to moderate Knee osteoarthritis: non-inferiority study protocol for a parallel, single-center randomized controlled trial

Abstract

Background: Knee osteoarthritis engenders a profound societal and economic burden while significantly compromising the well-being of patients. Present clinical guidelines advocate for non-pharmacological conservative approaches encompassing exercise, health education, and weight reduction as pivotal therapeutic modalities. Notably, mind-body exercises such as Taichi and Yoga are highly recommended due to their substantial efficacy in alleviating knee osteoarthritis (KOA). However, the comparative evaluation of these exercises remains insufficient. Consequently, the objective of this study is to assess the efficacy and safety of Taichi and Yoga while exploring the level of acceptance among patients. Methods: This pilot trial adopts a randomized, controlled, and blinded design, both for the assessor and statistician. A total of 72 participants will be recruited and randomly assigned to either the Taichi group (n = 36) or the Yoga group (n = 36). The Taichi group will undergo an 8-week intervention involving Modified Eight-Stage Taichi therapy, followed by a 16-week follow-up period. On the other hand, the Yoga group will receive an 8-week intervention employing Hatha Yoga therapy, followed by a 16-week follow-up period. The primary outcome measure will be the alteration in the total Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores. The secondary outcome measures will include the numerical rating scale (NRS), Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI), the Patient Global Assessment (PGA), the Arabic Arthritis Self-Efficacy Scale-8 (ASES-8), the Short Form 12 (SF-12), EuroQol-5D (EQ-5D) , and patient acceptance. Data will be collected at baseline and at weeks 1, 4, 8, 12, and 24. Discussion: The study endeavors to evaluate the feasibility and effectiveness of Modified Eight-Stage of Taichi and Hatha yoga in ameliorating symptoms and enhancing the quality of life for KOA patients. The outcomes of this trial will contribute to the formulation of standardized mind-body exercise interventions for KOA, thereby establishing a solid clinical foundation for future large-scale clinical trials. Trial registration: A randomized controlled trial of modified eight-stage Taichi for intervention in mild to moderate knee osteoarthritis (ChiCTR2300067546) Registered on 2023/01/11