The Correlation Between Degeneration of Paraspinal Muscle and Outcome of Patients With Lumbar Spinal Stenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Visual Analog Score
研究概览
简要总结
The photographical and functional parameters of paravertebral muscle in patients with lumbar spinal stenosis will be measured to investigate the correlation between paravertebral muscle degeneration and symptoms and prognosis of patients.By measuring the parameters of paravertebral muscle with normal people, the differences between the patients and normal people will be compared to establish an appropriate paravertebral muscle evaluation method.
详细描述
It is a prospective observational study. This study will recruit 200 patients with lumbar spinal stenosis who will undertake posterior lumbar decompression and fusion surgery in our hospital.They all take preoperative lumbar mri examination and waist and back muscle strength test as well as recording their preoperative visual analogue scale,oswestry disability index, lumbar stiffness disability index score.All patients will receive a follow-up lasting for 1 year,and we will record patients outcomes,such as visual analogue scale,oswestry disability index and lumbar stiffness disability index score at each follow-up time. At the same time,we will recruit 100 healthy subjects without lumbar diseases or chronic lumbar pain. The difference of their age with patients was less than 5 years. Meanwhile, lumbar dorsal muscle strength test and lumbar mri examination were conducted, and visual analogue scale as well as oswestry disability index and lumbar stiffness disability index score was recorded in healthy subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with lumbar spinal stenosis
- •age>45 years old
- •without other spinal disease
- •without history of former spinal surgery
排除标准
- •With neuromuscular diseases
- •With hip joint or knee joint disease
- •Acute or severe chronic back pain of spinal stenosis that could interfere with the evaluation of endurance
- •Other serious diseases impacting the evaluation of endurance
结局指标
主要结局
Visual Analog Score
时间窗: the follow-up time of 12 months
Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome.
cross-sectional area of paraspinal muscles
时间窗: Baseline
the cross-sectional area of paraspinal muscles reflects the quantity of paraspinal muscles. Higher cross-sectional area of paraspinal muscles means larger paraspinal muscle.
Performance time of paraspinal muscle endurance test
时间窗: Baseine
Participants were asked to lie prone on a plinth and lift their sternum from the plinth, raising their upper body.While maintaining this position, participants were asked to keep their arms in line with the body axis and not in contact with the plinth. Task failure was determined by a drop in the angle of trunk of greater than 10°at any point. The time was recorded until task failure or until the maximum contraction duration was reached (300 s).
lumbar stiffness disability index
时间窗: Baseline
The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome.
functional cross-sectional area of paraspinal muscles
时间窗: Baseline
functional cross-sectional area of paraspinal muscles reflects the quality of paraspinal muscles. It means the lean paraspinal muscle.
The Oswestry Disability Index
时间窗: the follow-up time of 12 months
The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome.
次要结局
未报告次要终点