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
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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.</div></div><div><h3>Results</h3><div>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, <em>p</em> < 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.</div></div><div><h3>Conclusion</h3><div>Compared to CKMT alone, CKMT+PA offers significant improvements in pain relief, functional capacity, and quality of life in patients with degenerative LSS.</div></div><div><h3>Trial registration</h3><div>Clinical Research Information Service (CRIS) registry, KCT0008557.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"15 1","pages":"Article 101204"},"PeriodicalIF":3.0000,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and safety of combining pharmacopuncture therapy and acupotomy for treating patients with degenerative lumbar spinal stenosis: A pragmatic, assessor-blinded, randomized, controlled trial\",\"authors\":\"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\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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, <em>p</em> < 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.</div></div><div><h3>Conclusion</h3><div>Compared to CKMT alone, CKMT+PA offers significant improvements in pain relief, functional capacity, and quality of life in patients with degenerative LSS.</div></div><div><h3>Trial registration</h3><div>Clinical Research Information Service (CRIS) registry, KCT0008557.</div></div>\",\"PeriodicalId\":13644,\"journal\":{\"name\":\"Integrative Medicine Research\",\"volume\":\"15 1\",\"pages\":\"Article 101204\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-07-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Integrative Medicine Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2213422025000848\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Integrative Medicine Research","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2213422025000848","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
Effectiveness and safety of combining pharmacopuncture therapy and acupotomy for treating patients with degenerative lumbar spinal stenosis: A pragmatic, assessor-blinded, randomized, controlled trial
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.
期刊介绍:
Integrative Medicine Research (IMR) is a quarterly, peer-reviewed journal focused on scientific research for integrative medicine including traditional medicine (emphasis on acupuncture and herbal medicine), complementary and alternative medicine, and systems medicine. The journal includes papers on basic research, clinical research, methodology, theory, computational analysis and modelling, topical reviews, medical history, education and policy based on physiology, pathology, diagnosis and the systems approach in the field of integrative medicine.