Efficacy and Safety of Electrical Warm Needle Acupuncture for Knee Osteoarthritis: A Protocol for a Pilot, Assessor-Blinded, Randomized Controlled Trial

Abstract Background Knee osteoarthritis (KOA) is a common degenerative joint disease that causes significant pain and functional limitations in older adults. Traditionally, warm needle acupuncture is used for musculoskeletal pain, but the technique is associated with risks, such as burns and inconsistent thermal control. The study aims to evaluate the efficacy and safety of electrical warm needle acupuncture (EWNA). Methods This is a pilot two-armed assessor-blinded randomized controlled trial that compares EWNA, which aims to provide precise and consistent thermal stimulation, with electrical moxibustion for patients diagnosed with KOA based on clinical symptoms and radiographic findings. Participants will be randomly assigned to either the EWNA or the electrical moxibustion group. Both treatments will be administered in 12 sessions over 6 weeks. Results The primary outcome measure is the change in the pain score, measured via a numeric rating scale, from baseline to the end of treatment. Secondary outcomes included measured changes in the visual analog scale, K-WOMAC score, Patient Global Impression of Change score, and 5-Level EuroQol-5 Dimension score. An independent blinded evaluator will assess all the outcomes. Adverse events will be monitored and recorded throughout the trial. Conclusions This pilot trial provides preliminary evidence of the feasibility and therapeutic potential of EWNA for KOA. Trial registration This protocol has been registered with the Clinical Research Information Service (KCT0010600) and approved by the Institutional Review Board of Dongguk University Bundang Oriental Hospital (DUBOH 2025-0002). Graphical Abstract