Lee Jung Hee, Lee Hyun-Jong, Woo Sang Ha, Park Yu-Kyeong, Han Ji Hoon, Choi Ga-Young, Heo Eun Sil, Kim Jae Soo, Park Chung A, Lee Woo Dong, Yang Chang Sop, Kim Ae-Ran, Han Chang-Hyun
Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.
Department of Diagnostics, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.
J Pain Res. 2023 Mar 6;16:659-668. doi: 10.2147/JPR.S399132. eCollection 2023.
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.
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.
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.
This study provides baseline data for large-scale studies on the effectiveness and safety of acupotomy in LSS.
KCT0006234.
在韩国，针对腰椎管狭窄症（LSS）会进行针刀、针灸和物理治疗等综合治疗。虽然有关于针刀作为LSS单一疗法或针灸治疗的报道，但缺乏实用研究。因此，本研究旨在确定针刀治疗LSS的有效性和安全性，为大规模研究提供基线证据。
本实用随机对照试验性研究招募了34名参与者，并将他们随机分为两组（每组n = 17）。干预持续8周。针刀加常规护理组每周接受两次针灸（17个穴位）和干扰电疗法（ICT）；然而，针刀加组额外接受针刀治疗（7个穴位），而常规护理组仅接受上述治疗。主要结局使用视觉模拟量表（VAS）测量，次要结局使用自我评定步行距离、简式麦吉尔疼痛问卷（SF - MPQ）和奥斯维斯特残疾指数（ODI）进行评估。在基线以及干预开始后的第4、8和12周进行结局测量。每次就诊时评估不良事件。在筛查时和第8周进行血液学和生化检查。
总体而言，34名参与者中有33名完成了研究，常规护理组有一名参与者退出。两组在第4、8和12周时的VAS评分与基线相比均显著改善。此外，在第4、8和12周时，自我评定步行距离、SF - MPQ和ODI评分也比基线时显著改善。然而，两组之间的时间依赖性和组间时间交互作用没有显著差异。此外，未报告严重不良反应，血液学和生化结果也无显著差异。
本研究为关于针刀治疗LSS有效性和安全性的大规模研究提供了基线数据。
KCT0006234。
