The Spine & Nerve Centers of the Virginias, Charleston, West Virginia.
Department of Pain Management, Cleveland Clinic, Cleveland, Ohio.
Pain Med. 2022 Apr 8;23(4):625-634. doi: 10.1093/pm/pnac028.
The purpose of this study is to provide Level-1 objective, real-world outcome data for patients with lumbar spinal stenosis suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum.
The MOTION Study is a prospective, multicenter, randomized controlled trial comparing the mild® Procedure (minimally invasive lumbar decompression; Vertos Medical, Aliso Viejo, CA, USA) as a first-line therapy in combination with nonsurgical conventional medical management (CMM) vs CMM alone as the active control.
Patients in the test group received the mild Procedure at baseline. Both the mild+CMM group and the control group were allowed unrestricted access to conventional real-world therapies. Patient-reported outcomes included the Oswestry Disability Index, the Zurich Claudication Questionnaire, and the Numeric Pain Rating Scale. A validated Walking Tolerance Test, the incidence of subsequent lumbar spine interventions, and the occurrence of adverse events were used to measure objective outcomes.
Sixty-nine patients in each group were analyzed at 1-year follow-up. No device- or procedure-related adverse events were reported in either group. Results from all primary and secondary outcome measures showed statistical significance in favor of mild+CMM.
One-year results of this Level-1 study demonstrated superiority of mild+CMM over CMM alone for patients with lumbar spinal stenosis who were suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum. Use of the validated Walking Tolerance Test to objectively measure increased ability to walk without severe symptoms provided evidence of statistically significantly better outcomes for mild+CMM than for CMM alone. With no reported device or procedure-related adverse events, the long-standing safety profile of the mild Procedure was reaffirmed. mild is a safe, durable, minimally invasive procedure that has been shown to be effective as an early interventional therapy for patients suffering from symptomatic lumbar spinal stenosis.
本研究旨在提供 1 级客观的真实世界结局数据，以评估伴有黄韧带骨化导致的神经源性跛行的腰椎管狭窄症患者接受微创腰椎减压术（Vertos Medical，加利福尼亚州艾尔西诺，美国）联合非手术常规药物治疗（CMM）的效果。
MOTION 研究是一项前瞻性、多中心、随机对照临床试验，比较微创腰椎减压术（minimally invasive lumbar decompression；Vertos Medical，加利福尼亚州艾尔西诺，美国）作为一线治疗与 CMM 联合治疗（轻度+CMM 组），与 CMM 单药治疗（对照组）的效果。
试验组患者在基线时接受微创腰椎减压术治疗。轻度+CMM 组和对照组都允许接受不受限制的常规真实世界治疗。患者报告的结局指标包括 Oswestry 功能障碍指数、苏黎世跛行问卷和数字疼痛评分量表。验证的步行耐受试验、后续腰椎手术干预的发生率和不良事件的发生情况用于衡量客观结局。
两组各有 69 例患者在 1 年随访时进行了分析。两组均未报告与器械或手术相关的不良事件。所有主要和次要结局指标的结果均表明轻度+CMM 组具有统计学优势。
这项 1 级研究的 1 年结果表明，对于伴有黄韧带骨化导致的神经源性跛行的腰椎管狭窄症患者，微创腰椎减压术联合 CMM 治疗优于 CMM 单药治疗。使用验证的步行耐受试验客观地衡量无严重症状行走能力的增加，为轻度+CMM 组提供了比 CMM 单药治疗更好的统计学结果。由于未报告与器械或手术相关的不良事件，微创腰椎减压术的长期安全性得到了再次确认。微创腰椎减压术是一种安全、持久、微创的治疗方法，已被证明对有症状的腰椎管狭窄症患者作为早期介入治疗是有效的。
