Effectiveness, Safety, and Cost-Effectiveness of Ultrasound-Guided Acupotomy for Degenerative Cervical Radiculopathy: A Protocol for a Randomized Controlled Trial

Abstract

Background Degenerative cervical radiculopathy (CR) causes neck and upper-extremity pain, sensory disturbance, and motor dysfunction resulting from nerve root compression or irritation by disc herniation, foraminal narrowing, or spondylotic changes. Ultrasound-guided acupotomy (UA), a minimally invasive acupuncture-based intervention, permits real-time visualization of target tissues and adjacent neurovascular structures, enabling controlled release of fibrotic or adhesive soft tissues that may contribute to nerve root compression. Evidence on its effectiveness, safety, and cost-effectiveness remains limited. Methods This two-arm, parallel, single-center randomized controlled trial will enroll 56 patients with clinically and radiologically confirmed degenerative CR, randomized 1:1 to UA or conventional physical therapy (CPT; interferential current therapy and microwave diathermy). Both groups will receive six sessions over 3 weeks, with follow-up at weeks 4, 7, and 11. The primary outcome is the between-group difference in mean change from baseline in visual analog scale scores for cervical and/or upper-extremity pain/discomfort at week 4. Secondary outcomes include painDETECT, Neck Disability Index, EuroQol 5-dimension 5-level, Depression Anxiety Stress Scales-21, Patient Global Impression of Change, clinically important difference, rescue medication use, Work Productivity and Activity Impairment, and cervical multifidus stiffness on shear wave elastography (SWE), interpreted as exploratory. Adverse events will be recorded at every visit. Conclusion This trial will evaluate the effectiveness, safety, and cost-effectiveness of UA versus CPT for degenerative CR. By integrating clinical outcomes, economic evaluation, magnetic resonance imaging-based foraminal stenosis grading, and exploratory SWE assessment, findings may provide comprehensive evidence on the role of UA in CR management. Ethics and Dissemination This protocol was approved by the Institutional Review Board of Pusan National University Korean Medicine Hospital. Written informed consent will be obtained from each participant after the study aims, procedures, and potential risks have been explained. Trial Registration Clinical Research Information Service, KCT0011139; registered on 12 November 2025.