背景:斜向腰椎椎间融合术(OLIF)是一种国际上流行的微创技术,用于治疗各种腰椎疾病。OLIF技术自2014年引入中国以来,在重建椎间稳定性方面已明显显示出其优越性,恢复椎间隙高度,实现间接减压,恢复正常的腰椎序列.然而,一些患者在OLIF后仍然有持续的症状,包括腰痛和酸痛,间接影响整体手术疗效和患者满意度。因此,一些临床医生建议患者在OLIF后常规使用脊柱矫形器,以减轻下背部肌肉和韧带的压力,从而缓解或避免术后残留症状或新症状。因此,OLIF后使用脊柱矫形器已成为必不可少的选择。然而,脊柱矫形器在OLIF中的作用及其对术后患者临床结局的具体影响尚不清楚,缺乏强有力的临床证据来间接或直接支持脊柱矫形器在OLIF中的作用,并证明其对患者临床结局的影响.这项研究旨在通过根据OLIF后使用或不使用脊柱矫形器对患者进行分组来研究脊柱矫形器在OLIF中的作用,从而为广大患者和医师提供更好的依据。
方法:我们计划进行一项为期1年的随机对照试验,涉及60名受试者。受试者将被随机分为两组:A组(手术后戴脊柱矫形器)和B组(手术后不戴脊柱矫形器)。这些患者的临床结果将使用Oswestry残疾指数进行评估,视觉模拟量表,还有Brantigan,Steffee,Fraser手术前1天和手术后2周以及1、6和12个月。
结论:本随机对照试验旨在为进一步的综合试验设计提供参考。这项研究的结果将为接受这种手术的患者的术后康复和治疗的选择提供更好,更科学的依据。
背景:本研究已在中国临床试验注册中心注册(注册编号::ChiCTR2200059000)。注册日期:2022年4月22日。注册网址:http://www。chictr.org.cn/showproj.aspx?proj=166310。
BACKGROUND: Oblique lumbar interbody fusion (OLIF) is an internationally popular minimally invasive technology for the treatment of various lumbar diseases. Since its introduction to China in 2014, OLIF technology has clearly shown its superiority in reconstructing intervertebral stability, restoring intervertebral space height, achieving indirect decompression, and restoring normal lumbar sequence. However, some patients still suffer from persistent symptoms after OLIF, including low back pain and soreness, which indirectly affect the overall surgical efficacy and patient satisfaction. Therefore, some clinicians recommend that patients routinely use spinal orthoses after OLIF to reduce the stress on the lower back muscles and ligaments, thereby relieving or avoiding postoperative residual symptoms or new symptoms. Accordingly, spinal orthosis use after OLIF has emerged as an essential option. However, the role of spinal orthoses in OLIF and their specific impact on postoperative patient clinical outcomes have remained unclear, and there is a lack of strong clinical evidence to indirectly or directly support the role of spinal orthoses in OLIF and demonstrate their impact on patient clinical outcomes. This
study aims to investigate the role of spinal orthoses in OLIF by grouping patients based on the use or nonuse of spinal orthosis after OLIF, thus providing a better basis for the majority of patients and physicians.
METHODS: We plan to conduct a 1-year randomized controlled
trial involving 60 subjects. The subjects will be randomized into two groups: group A (those wearing spinal orthoses after surgery) and group B (those not wearing spinal orthoses after surgery). The clinical outcomes of these patients will be evaluated using the Oswestry disability index, visual analog scale, and Brantigan, Steffee, Fraser 1 day before surgery and 2 weeks and 1, 6, and 12 months after surgery.
CONCLUSIONS: This randomized controlled trial aims to provide a reference for further comprehensive
trial design. The findings of this
study will provide a better and more scientific basis for the choice of postoperative rehabilitation and treatment for patients undergoing such a procedure.
BACKGROUND: This
study has been registered in the Chinese Clinical
Trial Registry (Registration No.: ChiCTR2200059000). Registration date: April 22, 2022. Registration website: http://www.chictr.org.cn/showproj.aspx?proj=166310.