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

Researchers in China are conducting a study to determine whether electroacupuncture can effectively relieve pain in people with osteonecrosis of the femoral head (ONFH), a progressive hip condition where bone tissue dies due to lack of blood supply. Pain is the main symptom that affects quality of life in ONFH patients.

This study will include 176 participants who will be randomly assigned to receive either real electroacupuncture or sham (fake) acupuncture twice weekly for 4 weeks. The real treatment involves placing acupuncture needles at specific points around the hip and buttock area (GB30, GB29, ST31, BL54, and pain points), with mild electrical stimulation applied through the needles. The sham treatment uses shallow needling at non-acupuncture points without actual electrical stimulation. Importantly, neither the participants, practitioners, nor outcome assessors will know who receives which treatment, making this a rigorous scientific study.

Researchers will measure pain levels, hip function, psychological wellbeing, quality of life, and any side effects at multiple time points up to 16 weeks after treatment begins. The main question is whether a meaningful proportion of patients experience significant pain reduction after 4 weeks of treatment.

This is a protocol publication, meaning the study is planned but results are not yet available. If electroacupuncture proves effective, it could offer a non-pharmaceutical option for managing ONFH pain. However, patients should wait for the actual results before drawing conclusions. If you're considering acupuncture for any condition, seek treatment from a licensed acupuncturist with appropriate credentials in your jurisdiction.

This triple-blind, sham-controlled RCT protocol aims to evaluate electroacupuncture efficacy for pain management in osteonecrosis of the femoral head. The study will randomize 176 participants (1:1) to receive either active EA at GB30, GB29, ST31, BL54, and Ashi points or sham EA (superficial non-acupoint needling with deactivated electrical device) twice weekly for 4 weeks. The primary outcome measures the proportion of patients achieving clinically meaningful pain reduction at 4 weeks post-treatment initiation. Secondary outcomes include VAS scores, sustained pain improvement through 16 weeks, modified Harris Hip Score, psychological measures (PHQ-9, GAD-7, PCS, PSEQ), SF-12 quality of life assessment, pain sensitization testing, analgesic consumption, and adverse events. Analysis will follow intention-to-treat principles. This rigorously designed study addresses the evidence gap regarding EA for ONFH-related pain, a condition with limited non-surgical management options. The triple-blinding and validated sham control enhance methodological quality, potentially providing high-level evidence for clinical decision-making in this challenging patient population.