Efficacy of core muscle strengthening training around the knee compared to oral nonsteroidal anti-inflammatory drugs in early-stage knee osteoarthritis patients: protocol for a randomized controlled trial.

BACKGROUND: Knee osteoarthritis (KOA) is a prevalent condition characterized by a high incidence and disability rate, making early intervention particularly critical. It is essential to focus on addressing the underlying disease rather than solely alleviating symptoms through pharmacological treatments. The Osteoarthritis Research Society International recommends non-pharmacological therapies as the primary intervention strategy, with physical therapy identified as the principal method. Current rehabilitation training programs often present challenges, including prolonged treatment durations, complex procedures, and the necessity for medical supervision. Preliminary clinical observations suggest that core muscle strengthening training around the knee (CMSTK) may effectively reduce pain, enhance mobility, improve quality of life, and avoid the aforementioned limitations. Nevertheless, further high-quality research with larger sample sizes is required to validate its efficacy conclusively. This study aims to investigate the specific effectiveness of CMSTK for the treatment of EKOA. METHODS: This study is a 12-week single-blind non-inferiority randomized controlled trial. One hundred early-stage knee osteoarthritis (EKOA) patients will be recruited and randomly divided into CMSTK group and oral nonsteroidal anti-inflammatory drugs group. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and secondary outcomes involves VAS, SF-36, ROM, and isometric strength. They will be conducted before allocation and at 2, 4, 8, and 12 weeks after allocation. Comprehensive efficacy will be evaluated by WOMAC. Data collectors and statisticians will be blinded, and participants will be asked not to reveal their allocation to assessors. DISCUSSION: The findings of this research will enhance the therapeutic approaches for early intervention in KOA, offer a scientific foundation for enabling patients with EKOA to engage in self-directed exercise, and contribute to the alleviation of social, medical, and economic burdens associated with the condition. TRIAL REGISTRATION: Chinese Clinical Trials Registry ChiCTR2400089758. Prospectively registered on 14 September 2024.