Effect of Transcutaneous Electrical Acupoint Stimulation on Postmenopausal Osteoporosis-Related Pain: Study Protocol for a Randomized, Sham-Controlled Trial

Introduction: Pain is a common symptom among postmenopausal women with osteoporosis and can substantially impair physical function and quality of life. Transcutaneous electrical acupoint stimulation (TEAS) has been increasingly used for pain management; however, evidence regarding its effectiveness in postmenopausal osteoporosis-related pain remains limited. This study aims to evaluate the efficacy and safety of TEAS in this population. Methods and Analysis: This prospective, single-center, participant-and assessor-blinded, randomized, sham-controlled trial will enroll 146 postmenopausal women with osteoporosis-related pain. Participants will be randomly assigned to either the TEAS group or the sham TEAS group in a 1:1 ratio. All participants will receive oral calcitriol soft capsules (0.25 μg/day) for 8 weeks. The TEAS group will receive stimulation at bilateral Pishu (BL20), Shenshu (BL23), Zusanli (ST36), and Sanyinjiao (SP6) once every other day for 8 weeks, while the sham TEAS group will receive identical procedures without therapeutic electrical stimulation. The primary outcome will be the change in visual analogue scale (VAS) score from baseline to week 8. Secondary outcomes will include changes in VAS scores from baseline to weeks 4 and 12, pain responder rate, lumbar spine bone mineral density (BMD), serum osteoprotegerin (OPG), serum calcium, serum neuropeptide Y (NPY), and quality of life assessed using the Short Form-36 (SF-36). Safety outcomes will also be evaluated. Data analysis will follow the intention-to-treat principle. Ethics/Dissemination: The study has been approved by the Medical Ethics Committee of Linping Campus, Second Affiliated Hospital, Zhejiang University School of Medicine (4 June 2026; approval No.2026-011). Findings will be disseminated through peer-reviewed publications and academic conferences. Trial Registration: Registered in the International Traditional Medicine Clinical Trial Registry (ITMCTR) with the registration number ITMCTR2026002224 (https://itmctr.ccebtcm.org.cn/, 31 August 2026).