Effectiveness, Safety, and Economic Evaluation of Ultrasound-Guided Acupotomy for Degenerative Lumbar Spinal Stenosis Compared with Conventional Physical Therapy: A Randomized Controlled Trial Protocol.

PURPOSE: Acupotomy is an emerging minimally invasive option for patients with degenerative lumbar spinal stenosis (LSS) whose symptoms persist despite conventional conservative care; however, conventional blind procedures raise concerns about procedural safety and target localization. Ultrasound-guided acupotomy (UA) provides real-time visualization of lumbar anatomical structures and may improve procedural precision. This randomized controlled trial (RCT) protocol describes a study designed to compare UA with conventional physical therapy (CPT) in patients with LSS by assessing clinical effectiveness, safety, shear wave elastography (SWE)-assessed biomechanical changes, and cost-effectiveness.

PATIENTS AND METHODS: This prospective, single-center, assessor-blinded, superiority RCT will enroll 64 patients with magnetic resonance imaging (MRI)-confirmed degenerative LSS. Participants will be randomized 1:1 to receive either UA or CPT, consisting of transcutaneous electrical nerve stimulation and microwave diathermy, twice weekly for 4 weeks. The primary outcome, upon which the sample size estimation is based, is the between-group difference in change from baseline in the Visual Analog Scale (VAS) pain score at Week 5, after 1 week of treatment. Secondary outcomes include VAS scores at Weeks 8 and 12; functional and quality-of-life outcomes assessed using the Zurich Claudication Questionnaire, Oswestry Disability Index, EuroQol-5 Dimensions, and maximum walking distance; exploratory quantitative SWE-assessed multifidus muscle stiffness; and adverse events. Clinical effectiveness will be analyzed using analysis of covariance in the full analysis set. A within-trial cost-utility analysis will also be performed from the healthcare system perspective to estimate the incremental cost-effectiveness ratio.

CONCLUSION: This protocol builds on a previous pilot study by incorporating assessor blinding, MRI-based diagnostic criteria, SWE-based biomechanical assessment, and cost-utility analysis. By integrating confirmatory clinical outcomes with safety, biomechanical, and economic outcomes, this trial is expected to generate evidence that may support clinical decision-making and inform future economic considerations for UA in the management of LSS.