Evaluating the clinical efficacy of five-step knee adjustment manipulation based on the ‘muscle and bone balance’ principle in treating KOA and the influence on the biomechanical characteristics of soft tissues

Abstract Background Knee osteoarthritis (KOA) is the leading cause of knee joint dysfunction. While manual treatments are effective, most traditional methods focus solely on the knee joint or its surrounding tissues, neglecting the impact of the waist, hip, ankle, and lower limb alignment on KOA. The objective is to clarify the effects of the five-step knee adjustment manipulation on KOA, evaluate its efficacy, and explore new treatment approaches for manual KOA therapy. Methods (1) Observe the differences in lower limb alignment, quadriceps cross-sectional area, knee joint range of motion (ROM), and gait between healthy individuals and KOA participants. (2) Conduct a multi-center, randomized, single-blind, controlled clinical trial. Eligible cases will be included, with conventional knee joint massage as the control. The five-step knee adjustment manipulation will be assessed by evaluating knee joint VAS and WOMAC scores, knee joint ROM, fastest 15-meter walking time, lower limb alignment, quadriceps cross-sectional area, and gait analysis. Discussion This technique emphasizes a holistic approach, addressing the lumbar spine, hip, knee, and ankle joints, as well as related muscle groups, to correct lower limb alignment and restore muscle and bone balance. We think it will contribute to providing a promising alternative intervention for middle-aged and older adults with KOA. Trial registration: The study was approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (Ethics No.: 2024SHL-KY-70-01.) China Registered Clinical Trial Registration Center (ChiCTR2400085536). Registered on Jun. 12. 2024.