Three-year results of the MOTION randomized controlled trial for treatment of lumbar spinal stenosis using the percutaneous mild® Procedure

Shrif J. Costandi , Timothy R. Deer , Timothy B. Chafin , Christopher Kim
{"title":"Three-year results of the MOTION randomized controlled trial for treatment of lumbar spinal stenosis using the percutaneous mild® Procedure","authors":"Shrif J. Costandi ,&nbsp;Timothy R. Deer ,&nbsp;Timothy B. Chafin ,&nbsp;Christopher Kim","doi":"10.1016/j.inpm.2025.100561","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>The MOTION prospective, multicenter randomized controlled trial compares the outcomes of percutaneous image-guided lumbar decompression in combination with conventional medical management (CMM) to the use of CMM alone for the treatment of lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. The study includes extended follow-up for patients in both the treatment group and for those who crossed over from the control group to the treatment group.</div></div><div><h3>Methods</h3><div>The treatment group received the <em>mild</em>® Procedure (Vertos Medical, Aliso Viejo, CA, USA) in combination with nonsurgical CMM, while the active control group received CMM alone. There were no restrictions for either group regarding access to real-world CMM therapies. Patients reported outcomes using the Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and Numeric Pain Rating Scale (NPRS). Objective outcomes were measured using a validated Walking Tolerance Test (WTT), the incidence of subsequent lumbar spine interventions, and the occurrence of adverse events.</div></div><div><h3>Results</h3><div>Forty-eight patients initially receiving <em>mild</em> + CMM consented to extended follow-up and were available for 3-year follow-up. All outcomes for this group were significantly improved over baseline (p-values ranging from &lt;0.0001 to 0.0001). At 3-year, ODI, NPRS back and leg, ZCQ symptom severity, and physical function improved by 16.9, 3.0, 4.3, 0.8, and 0.6, respectively. Walking tolerance test demonstrated 274 % improvement from baseline, and only 4 (5.6 %) patients had received surgical intervention. No device- or procedure-related adverse events were reported.</div></div><div><h3>Conclusions</h3><div>MOTION 3-year follow-up results continue to demonstrate the safety and durability of the <em>mild</em> Procedure combined with CMM for early interventional treatment of symptomatic LSS. The absence of device or procedure-related adverse events further underscores the robust safety profile of the <em>mild</em> Procedure. Significant and substantial improvements in all the outcomes were observed from baseline to follow-up for patients treated with the <em>mild</em> Procedure. These results support the <em>mild</em> Procedure as an effective approach for early intervention in LSS treatment.</div></div>","PeriodicalId":100727,"journal":{"name":"Interventional Pain Medicine","volume":"4 1","pages":"Article 100561"},"PeriodicalIF":0.0000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Interventional Pain Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2772594425000226","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Objective

The MOTION prospective, multicenter randomized controlled trial compares the outcomes of percutaneous image-guided lumbar decompression in combination with conventional medical management (CMM) to the use of CMM alone for the treatment of lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. The study includes extended follow-up for patients in both the treatment group and for those who crossed over from the control group to the treatment group.

Methods

The treatment group received the mild® Procedure (Vertos Medical, Aliso Viejo, CA, USA) in combination with nonsurgical CMM, while the active control group received CMM alone. There were no restrictions for either group regarding access to real-world CMM therapies. Patients reported outcomes using the Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and Numeric Pain Rating Scale (NPRS). Objective outcomes were measured using a validated Walking Tolerance Test (WTT), the incidence of subsequent lumbar spine interventions, and the occurrence of adverse events.

Results

Forty-eight patients initially receiving mild + CMM consented to extended follow-up and were available for 3-year follow-up. All outcomes for this group were significantly improved over baseline (p-values ranging from <0.0001 to 0.0001). At 3-year, ODI, NPRS back and leg, ZCQ symptom severity, and physical function improved by 16.9, 3.0, 4.3, 0.8, and 0.6, respectively. Walking tolerance test demonstrated 274 % improvement from baseline, and only 4 (5.6 %) patients had received surgical intervention. No device- or procedure-related adverse events were reported.

Conclusions

MOTION 3-year follow-up results continue to demonstrate the safety and durability of the mild Procedure combined with CMM for early interventional treatment of symptomatic LSS. The absence of device or procedure-related adverse events further underscores the robust safety profile of the mild Procedure. Significant and substantial improvements in all the outcomes were observed from baseline to follow-up for patients treated with the mild Procedure. These results support the mild Procedure as an effective approach for early intervention in LSS treatment.
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信