Feasibility, Safety, and Effectiveness of Ultrasound-Guided Acupotomy Treatment for Degenerative Lumbar Spinal Stenosis: A Pilot Randomized Controlled Trial.

PURPOSE: To evaluate the feasibility, safety, and preliminary clinical effect of ultrasound-guided acupotomy (UA) compared with conventional physical therapy (CPT) in patients with degenerative lumbar spinal stenosis (LSS). PATIENTS AND METHODS: This single-center, pilot randomized controlled trial included 50 participants with degenerative LSS, randomized in a 1:1 ratio to receive either UA or CPT (transcutaneous electrical nerve stimulation and microwave diathermy). Both groups underwent eight treatment sessions over 4 weeks. Feasibility was assessed through recruitment, attrition rates, and protocol adherence, while safety was monitored through adverse events (AEs). Clinical outcomes, including the Visual Analog Scale (VAS), Zurich Claudication Questionnaire (ZCQ), Oswestry Disability Index (ODI), maximum walking distance, and EuroQol 5-Dimension (EQ-5D), were measured at baseline and at weeks 5, 8, and 12. RESULTS: The attrition rate was 8.0% (UA: 0% [n=0] vs CPT: 16.0% [n=4]), and protocol adherence was 98.3% (UA: 100% [200/200 sessions] vs CPT: 96.5% [193/200 sessions]). No serious intervention-related AEs, specifically iatrogenic neural or vascular injuries, occurred. Minor AEs in the UA group were mild and resolved spontaneously. At follow-up assessments, the UA group exhibited statistically significantly greater improvements in VAS, ZCQ, and EQ-VAS scores compared to the CPT group (p < 0.05). Significant intergroup differences in ODI and EQ-5D were observed only at weeks 8 and 12, respectively. Regarding VAS scores, improvements in the UA group were sustained over time, whereas the CPT group showed a gradual decline in therapeutic effects. CONCLUSION: UA demonstrated feasibility, acceptable short-term procedural safety, and tolerability for degenerative LSS, suggesting potential short-term benefits in pain relief and functional recovery compared with CPT. These exploratory results warrant future large-scale confirmatory clinical trials.