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

Jihun Kim; Chang-Hyun Han; Taewook Lee; Sookwang An; Changsop Yang; Young Eun Choi; Byoung-Kab Kang; Yoona Oh; Kun Hyung Kim; Gi Young Yang; Eunseok Kim

doi:10.1016/j.imr.2025.101204

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

Integr Med Res. 2026 Mar;15(1):101204. doi: 10.1016/j.imr.2025.101204. Epub 2025 Jul 18.

Authors

Jihun Kim^{1

2}, Chang-Hyun Han^{3

4}, Taewook Lee¹, Sookwang An¹, Changsop Yang³, Young Eun Choi⁵, Byoung-Kab Kang³, Yoona Oh^{1

6}, Kun Hyung Kim^{1

6}, Gi Young Yang^{1

6}, Eunseok Kim^{1

6}

Affiliations

¹ Department of Acupuncture and Moxibustion Medicine, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.
² Department of Korean Medicine, Graduate School of Pusan National University, Yangsan, Republic of Korea.
³ KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
⁴ Korean Convergence Medicine, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
⁵ Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
⁶ Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.

Abstract

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.

Results: The CKMT+PA group showed significant improvements in VAS scores compared to the CKMT group at 6 weeks (adjusted mean difference: 20.26; 95 % confidence interval: 13.79-26.72, p < 0.0001), and a higher proportion of patients in the CKMT+PA group achieved the minimal CID in pain reduction. 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.

Keywords: Acupotomy; Korean Medicine; Lumbar spinal stenosis; Pharmacopuncture; Randomized controlled trial.