Efficacy of electroacupuncture for pain relief in patients with osteonecrosis of the femoral head: protocol for a randomised, triple-blind, sham-controlled trial

INTRODUCTION: Osteonecrosis of the femoral head (ONFH) is a progressive and disabling condition, with pain being its predominant symptom. Electroacupuncture (EA) has shown promise in the management of chronic pain; however, high-quality evidence on its efficacy and safety in ONFH is still lacking. The aim of this trial is to evaluate the efficacy and safety of EA for pain relief in ONFH. METHODS AND ANALYSIS: This triple-blind, sham-controlled, parallel-group randomised controlled trial will be conducted at a single centre in China and will include 176 participants with ONFH. Participants will be randomly allocated (1:1) to receive either active EA or sham EA. The active intervention involves EA applied to specific acupoints (GB30, GB29, ST31, BL54 and Ashi points) twice weekly for 4 weeks. Sham EA consists of superficial needling at non-acupoint locations using a deactivated device. The primary outcome is the proportion of patients achieving a clinically meaningful reduction in pain at 4 weeks (end of treatment). Secondary outcomes are changes in the Visual Analogue Scale score, the proportion of participants achieving clinically significant pain improvement at weeks 8, 12 and 16, modified Harris Hip Score, psychological scales (Patient Health Questionnaire-9, Generalised Anxiety Disorder-7, Pain Catastrophising Scale, Pain Self-Efficacy Questionnaire), the 12-Item Short Form Health Survey, pain sensitisation tests, rescue analgesic use and the incidence of adverse events. Data will be analysed using the intention-to-treat principle, and appropriate statistical models will be used to compare the primary outcome between groups. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Luoyang Orthopedic Hospital of Henan Province (Approval No: 2025ZXKT0001-02). Written informed consent will be obtained from all participants prior to enrolment. The results of this trial will be disseminated regardless of the findings through publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN15751942.