Journal of Pain Research (Mar 2023)
Effectiveness and Safety of Acupotomy on Lumbar Spinal Stenosis: A Pragmatic, Pilot, Randomized Controlled Trial
Abstract
Jung Hee Lee,1,* Hyun-Jong Lee,1,* Sang Ha Woo,1 Yu-Kyeong Park,1 Ji Hoon Han,1 Ga-Young Choi,1 Eun Sil Heo,1 Jae Soo Kim,1 Chung A Park,2 Woo Dong Lee,3 Chang Sop Yang,4 Ae-Ran Kim,5 Chang-Hyun Han4,6 1Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea; 2Department of Diagnostics, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea; 3Pre-Major of Cosmetics and Pharmaceutics, College of Herbal Bio-Industry, Daegu Haany University, Daegu, Republic of Korea; 4KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 5Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 6Korean Convergence Medicine, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea*These authors contributed equally to this workCorrespondence: Chang-Hyun Han, KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea, Tel +82 42 868 9498, Fax +82 42 869 2775, Email [email protected]: In Korea, complex treatments such as acupotomy, acupuncture, and physical therapy are performed for lumbar spinal stenosis (LSS). Although there are reports of acupotomy as monotherapy or acupuncture treatment for LSS, pragmatic studies are lacking. Therefore, this study aimed to determine the effectiveness and safety of acupotomy for LSS to provide baseline evidence for a large-scale study.Materials and Methods: This pragmatic randomized controlled pilot study enrolled 34 participants and randomly assigned them to two groups (n=17/group). The intervention was conducted for 8 weeks. Acupotomy plus and usual care groups received acupuncture (17 acupoints) and interferential current therapy (ICT) twice weekly; however, the acupotomy plus group received an additional acupotomy (7 acupoints) for treatment of the usual care group. The primary outcome was measured using visual analog scales (VAS), and secondary outcomes were assessed using the self-rated walking distance, short-form McGill Pain Questionnaire (SF-MPQ), and the Oswestry Disability Index (ODI). Outcome measurements were conducted at baseline and 4, 8, and 12 weeks after the commencement of the intervention. Adverse events were assessed at each visit. Hematological and biochemical examinations were performed at screening and week 8.Results: Overall, 33 of the 34 participants completed the study, and one participant in the usual care group dropped out. In both groups, VAS scores at weeks 4, 8, and 12 significantly improved compared to baseline. Also, self-rated walking distance, SF-MPQ, and ODI scores were significantly improved at weeks 4, 8, and 12 than at baseline. However, there were no significant differences in the time-dependent and group-to-time interactions between the two groups. In addition, no severe adverse reactions were reported, and there were no significant differences in hematological and biochemical results.Conclusion: This study provides baseline data for large-scale studies on the effectiveness and safety of acupotomy in LSS.Clinical Trial Number: KCT0006234.Keywords: complementary therapy, pragmatic clinical trial, low back pain, acupuncture therapy
