Opposing Needling in the treatment of Knee Osteoarthritis: An Improved Study Protocol for a Randomized Controlled Trial

Huiying Li¹Siyu Qian¹Xi Wu^1*Tingting Luo^1*Yanqin Liu²Yan Guo³xiaoqin qin Chen²Yao Hu³Qiyue Fu³Qing Li³Yuting Xiang³Ying Liu³

• ¹Chengdu University of Traditional Chinese Medicine, Chengdu, China
• ²Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu, China
• ³The Thirteenth People's Hospital of Chongqing, Chongqing, China

Background: Knee osteoarthritis (KOA) is a common degenerative joint disease that typically affects individuals over 40 years of age and is characterized by knee pain, stiffness, and functional impairment. Current treatment options, including basic care, pharmacologic therapy, and surgery, often provide limited pain relief or are associated with adverse effects, high costs, and surgical risks. Acupuncture has been conditionally recommended by international guidelines for KOA management and has shown beneficial effects in alleviating pain and improving function. However, most studies have investigated single modalities such as manual acupuncture or electroacupuncture, leaving opportunities to explore strategies that may further enhance therapeutic outcomes. Opposing needling, a classical technique involving contralateral point selection, has demonstrated superior analgesic effects in various chronic pain conditions and is increasingly applied in KOA. Methods: This two-center randomized controlled trial will enroll 108 eligible patients with KOA, who will be randomly assigned in a 1:1:1 ratio to opposing needling plus electroacupuncture, sham opposing needling plus electroacupuncture, or electroacupuncture alone. The 12-week study comprises an 8-week intervention period and a 4-week follow-up, with treatments administered three times per week. The primary outcome will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), while secondary outcomes will include WOMAC subscales, Visual Analogue Scale, Numeric Rating Scale, Global Pain Scale, Lequesne Index, Knee Injury and Osteoarthritis Outcome Score, and Short Form-36 Health Survey. Discussion: The findings are expected to provide robust evidence regarding the efficacy and safety of opposing needling as an adjunctive therapy for KOA and to inform optimized treatment strategies. Clinical trial registration: International Traditional Medicine Clinical Trial Registry (itmctr.ccebtcm.org.cn), ITMCTR2025001291.