Evaluating the Effect of Electroacupuncture in Knee Osteoarthritis: Protocol for a Multicenter Randomized Controlled Trial.

Researchers are launching a major study to understand how acupuncture helps knee osteoarthritis (KOA), a common condition causing knee pain and stiffness. While acupuncture has been used in China for thousands of years to treat knee pain, scientists want to determine exactly how effective it is and what happens in the brain when it works. This study will involve 110 patients aged 50-75 who have experienced chronic knee pain for at least three months. Participants will be randomly divided into two groups: one receiving real electroacupuncture (acupuncture with mild electrical stimulation) and another receiving fake acupuncture. Neither patients nor assessors will know which treatment they're receiving. The study will take place at three hospitals in China between 2024 and 2026, with treatment consisting of six sessions over two weeks. Researchers will measure pain levels, physical function, mood, and use advanced brain imaging (fMRI) to see how acupuncture affects brain activity and pain processing. What makes this study unique is combining patients' reports of pain relief with objective brain scans to understand the mechanism behind acupuncture's effects. The results should help clarify whether electroacupuncture truly works for knee osteoarthritis and reveal the brain changes responsible for pain relief. This research is still ongoing, so results aren't yet available, but the comprehensive approach should provide valuable insights for people considering acupuncture for knee pain. If you're interested in acupuncture for knee osteoarthritis, consult a licensed acupuncturist with experience treating musculoskeletal conditions.

This multicenter RCT protocol outlines a neuroimaging study evaluating electroacupuncture versus sham electroacupuncture for knee osteoarthritis. The trial will randomize 110 patients (ages 50-75) with chronic knee pain (≥3 months) in a 1:1 ratio across three Chinese hospitals. The patient- and assessor-blind design includes stratified block randomization with electronic allocation. Interventions consist of six sessions over two weeks. The primary outcome is the Clinical Global Impressions scale - Improvement, with secondary measures including VAS, pressure pain threshold, KOOS, and psychological assessments (SAS, SDS). Notably, multimodal fMRI will assess brain functional-structural changes and connectivity patterns, correlating neural markers with subjective outcomes. Statistical analysis will employ chi-square or t-tests for clinical data and general linear models for imaging comparisons. This protocol represents a methodologically rigorous approach integrating validated patient-reported outcomes with objective neuroimaging to elucidate both efficacy and central mechanisms of electroacupuncture for KOA. Results may provide evidence-based guidance for incorporating electroacupuncture in osteoarthritis treatment protocols.