Effectiveness and safety of combining pharmacopuncture therapy and acupotomy for treating patients with degenerative lumbar spinal stenosis: A pragmatic, assessor-blinded, randomized, controlled trial

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Background: In the clinical practice of Korean Medicine, pharmacopuncture therapy and acupotomy (PA) are being increasingly explored as potential treatment options for degenerative lumbar spinal stenosis (LSS). In this study, we aimed to evaluate the effectiveness and safety of combining PA with conventional Korean Medicine treatment (CKMT) in patients with degenerative LSS. Methods: A pragmatic, assessor-blinded, randomized controlled trial was conducted with 104 participants aged 40-75 years diagnosed with degenerative LSS. The participants were randomly assigned to either the CKMT+PA or CKMT alone groups over a 6-week period. The primary outcome was the mean change in the visual analog scale (VAS) for pain/discomfort. Secondary outcomes included clinically important differences (CID), Zurich Claudication Questionnaire, self-reported maximum walking distance, Roland-Morris Disability Questionnaire, EuroQol 5-dimension 5-level questionnaire, and patients' global impression of change. The adverse events (AEs) were assessed at each visit. These improvements persisted at weeks 10 and 14. Superior results were also observed with respect to secondary outcomes in the CKMT+PA group compared to the CKMT group across all time points. CKMT showed no AEs, while mild AEs occurred in 1.7 % of bee venom and 2.2 % of acupotomy sessions. Conclusion: Compared to CKMT alone, CKMT+PA offers significant improvements in pain relief, functional capacity, and quality of life in patients with degenerative LSS. Trial registration: Clinical Research Information Service (CRIS) registry, KCT0008557.