Efficacy and safety comparison of infrared laser moxibustion and traditional moxibustion in knee osteoarthritis: Study protocol for a Zelen- design randomized controlled non-inferiority clinical trial

Background Knee osteoarthritis (KOA), which is the most common chronic degenerative joint disease, places substantial burden on public health resources in China. The purpose of this study is to preliminary evaluate whether infrared laser moxibustion (ILM) is non-inferior to traditional moxibustion (TM) in the treatment of KOA. Methods In the designed Zelen-design randomized controlled non-inferiority clinical trial, a total of 74 patients with KOA will be randomly allocated to one of two interventions: ILM treatment or TM treatment. All participants will receive a 6-week treatment and be followed-up for 4 weeks. The primary outcome will be the mean change in pain on the numeric rating scale (NRS). The secondary outcomes will be the pain on the NRS from weeks 1 to 5 after the start of treatment and the changes from baseline to endpoints (weeks 6 and 10) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), SF-36, knee circumference, and 6-min walking test. In addition, safety assessment will be performed throughout the trial. Discussion The results of our study will help determine whether a 6-week treatment with ILM is non-inferior to TM in patients with KOA, therefore providing evidence for verifying if ILM can become a safer alternative for TM in clinical applications in the future. Trial registration: Clinical Trial Registration Platform (ChiCTR2200065264); Pre-results. Registered on 1 November 2022.