Effects of Transcutaneous Electrical Acustimulation on Patients with Fibromyalgia Syndrome: Study Protocol of a Randomized, Double-Blind, Sham-Controlled Trial

Background Fibromyalgia Syndrome (FMS) is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, and localized tenderness. Transcutaneous Electrical Acustimulation (TEA) is a non-invasive therapy that combines Traditional Chinese Medicine with electrical stimulation at specific acupoints. Previous studies have shown that TEA is effective in treating pain-related conditions. This study aims to evaluate the efficacy and mechanisms of TEA treatment for FMS. Design This is a prospective, randomized, double-blind, and placebo-controlled trial with two parallel groups, conducted at a single center. Forty participants will be randomly assigned to either the TEA group or the sham-TEA group in a 1:1 ratio. Participants will receive 2 weeks of treatment followed by 2 weeks of follow-up. The primary outcome is the change in VAS pain scores before and after treatment. Secondary outcomes include FMS and pain-related questionnaire scales, infrared thermography (IRT), vibration-controlled transient elastography (VCTE), blood neurobiological markers, cytokines, and metabolomics. Trial Registration http://itmctr.ccebtcm.org.cn/ identifier ITMCTR2024000638.