Costandi Shrif J, Deer Timothy R, Chafin Timothy B, Kim Christopher
Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH, 44195, USA.
The Spine & Nerve Centers of the Virginias, 400 Court Street, Suite 100, Charleston, WV, 25301, USA.
Interv Pain Med. 2025 Mar 12;4(1):100561. doi: 10.1016/j.inpm.2025.100561. eCollection 2025 Mar.
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.
The treatment group received the ® 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.
Forty-eight patients initially receiving + 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.
MOTION 3-year follow-up results continue to demonstrate the safety and durability of the 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 Procedure. Significant and substantial improvements in all the outcomes were observed from baseline to follow-up for patients treated with the Procedure. These results support the Procedure as an effective approach for early intervention in LSS treatment.
MOTION前瞻性多中心随机对照试验比较了经皮影像引导下腰椎减压联合传统药物治疗（CMM）与单纯使用CMM治疗肥厚性黄韧带继发神经源性间歇性跛行的腰椎管狭窄症的疗效。该研究包括对治疗组患者以及从对照组转入治疗组的患者进行延长随访。
治疗组接受®手术（Vertos Medical，美国加利福尼亚州阿利索维耶霍）联合非手术CMM，而活性对照组仅接受CMM。两组在获得实际CMM治疗方面均无限制。患者使用奥斯威斯利功能障碍指数（ODI）、苏黎世间歇性跛行问卷（ZCQ）和数字疼痛评分量表（NPRS）报告结果。使用经过验证的步行耐力测试（WTT）、后续腰椎干预的发生率和不良事件的发生情况来衡量客观结果。
48例最初接受+ CMM的患者同意延长随访，并可进行3年随访。该组所有结果均较基线有显著改善（p值范围从<0.0001到0.0001）。在3年时，ODI、NPRS背部和腿部、ZCQ症状严重程度和身体功能分别改善了16.9、3.0、4.3、0.8和0.6。步行耐力测试显示较基线提高了274%，只有4例（5.6%）患者接受了手术干预。未报告与器械或手术相关的不良事件。
MOTION 三年随访结果继续证明了联合CMM的手术用于有症状LSS早期介入治疗的安全性和持久性。未出现与器械或手术相关的不良事件进一步强调了该手术强大的安全性。接受该手术治疗的患者从基线到随访期间所有结果均有显著且实质性的改善。这些结果支持该手术作为LSS治疗早期干预的有效方法。
