NCT06622356已完成不适用
Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up
Hao Liu1 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2024年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- SAS（Pain rating scale）
研究概览
简要总结
The study was a clinical retrospective study designed to investigate risk factors for long-term recurrent pain after PLIF in patients with lumbar degenerative disease and to improve patient outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;
- •lumbar spinal fusion surgical treatment with PLIF;
- •grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 12-18 month postoperative follow-up;
- •observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.
排除标准
- •(1) those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.
结局指标
主要结局
SAS（Pain rating scale）
时间窗: 12-18 months after surgery
The visual analogue scale (VAS) was employed to determine the patient's perception of lower back pain or lower limb pain prior to surgery, as well as 12-18 months after surgery. (0-10 scale, with 0 being painless and 10 being the most painful)
次要结局
未报告次要终点
研究者
Hao Liu
Orthopedic surgeon, First Affiliated Hospital of Suzhou University, Jiangsu Province, China
First Affiliated Hospital of Suzhou Medical College
研究点 (1)
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