The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Change in Oswestry Disability Index (ODI) score following the surgery.
研究概览
简要总结
Braces are commonly prescribed after posterior spinal instrumented fusion (PSIF) in patients with lumbar degenerative conditions with the aim of improving pain relief and quality of life. However, there is a lack of evidence on the indication for postoperative bracing, as surgeons choose to use braces mainly based on their experience and training.
The aim of this study is to investigate whether wearing a brace after PSIF can improve pain relief and quality of life (QOL) 6 weeks and 3 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with degenerative lumbar spine disease (degenerative spondylolisthesis, spinal stenosis, or degenerative disc disease);
- •Patients scheduled for an elective posterior spinal fusion.
排除标准
- •Patients with obesity (BMI > 35kg/m2).
结局指标
主要结局
Change in Oswestry Disability Index (ODI) score following the surgery.
时间窗: Baseline, 6 weeks postoperatively, 3 months postoperatively
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
次要结局
- Change in SF-12v2 Mental Component Score (MCS)(Baseline, 6 weeks postoperatively, 3 months postoperatively.)
- Change in SF-12v2 Physical Component Score (PCS)(Baseline, 6 weeks postoperatively, 3 months postoperatively.)
- Change in Visual Analog Scale (VAS) for back pain(Baseline, 6 weeks postoperatively, 3 months postoperatively.)
研究者
Jean-Marc Mac-Thiong
MD, PhD
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal