Efficacy of electroacupuncture for painful cervical spondylotic radiculopathy and associated changes in cervical biomechanical measures: a study protocol for a randomized, sham-controlled clinical trial

BACKGROUND: Painful cervical radiculopathy due to cervical spondylosis (painful CSR) is characterized by radicular pain and neurological dysfunction. Conservative care commonly includes medication and physical therapy, but evidence for individual nonsurgical interventions remains uncertain. Electroacupuncture (EA) is a non-pharmacological option, but rigorous sham-controlled evidence in painful CSR remains limited. This trial aims to compare the complete EA protocol with the selected SEA protocol and to characterize accompanying changes in prespecified cervical biomechanical measures. METHODS/DESIGN: This single-center, randomized, sham-controlled trial will enroll 80 participants with painful CSR and randomly assign them 1:1 to EA or SEA. Participants, outcome assessors, and the data analyst will be blinded. Both groups will receive identical standardized common care, with EA or SEA delivered in 20 sessions over 4 weeks, followed by 24 weeks of post-treatment follow-up. The primary outcome is the Week-4 Visual Analog Scale (VAS) score, analyzed with adjustment for baseline VAS. Supportive key secondary outcomes are the Week-4 Neck Disability Index (NDI) and Week-4 mean resting upper-trapezius shear-wave speed (SWS) on the primary symptomatic side. Other secondary outcomes include ultrasound- and surface electromyography (sEMG)-derived biomechanical measures, Patient Global Impression of Change (PGIC), rescue-medication use, and the Short Form Health Survey (SF-36). Adverse events will be recorded through Week 28. DISCUSSION: This trial will estimate the comparative clinical effects of the complete EA protocol relative to the selected SEA protocol and assess whether prespecified cervical biomechanical measures change alongside clinical outcomes. The findings may inform future evaluation of EA as a non-pharmacological treatment for painful CSR. CLINICAL TRIAL REGISTRATION: The Chinese Clinical Trial Registry identifier is ChiCTR2300075726.