Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The purpose of this study is to evaluate the effect of baclofen in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability and patient satisfaction between control (conservative management for spinal stenosis) and baclofen group (conservative management for spinal stenosis plus baclofen treatment).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed lumbar spinal stenosis with MRI finding
- •nocturnal calf cramps symptoms at least once per week
排除标准
- •electrolyte disorder
- •congenital muscle disease
- •muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
- •cognitive impairments
研究组 & 干预措施
control group
conservative management for spinal stenosis
干预措施: gabapentin (neurontin® capsule 300mg) treatment (Drug)
baclofen group
conservative management for spinal stenosis plus baclofen treatment
干预措施: baclofen (baclofen Tab. 10mg) treatment (Drug)
结局指标
主要结局
Pain score
时间窗: follow up 4 weeks
A comparison of pain score between control (conservative management for spinal stenosis) and baclofen group (conservative management for spinal stenosis plus baclofen treatment). The pain score will be measured using NRS (Numeric Rating Scale) on a scale from 0-10, with 0 representing "no pain" and 10 "worst possible pain".
次要结局
- Frequency and severity of nocturnal calf cramps(follow up 4 weeks, 12 weeks)
- Patient satisfaction (PGIC)(follow up 4 weeks, 12 weeks)
- Insomnia severity index(follow up 4 weeks, 12 weeks)
- Oswestry Disability Index(follow up 4 weeks, 12 weeks)