Physical Therapy Versus Surgical Decompression for Lumbar Spinal Stenosis: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 3
- 主要终点
- The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
研究概览
简要总结
This is a randomized controlled multicenter trail comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis. The 0-hypothesis is that there is no difference in the efficacy of structured physical therapy compared to surgical decompression.
Our aim is to evaluate if physical therapy can serve as a nonsurgical alternative for patients with LSS, where the severity of symptoms indicates the need of surgical decompression.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients describing intermittent neurogenic claudication when walking and symptoms revealed by flexion of the spine.
- •MRI shows lumbar spinal stenosis in one or two levels measured.
- •The duration of the symptoms is longer than six months
- •The patient is a candidate for surgical treatment
- •The patient is capable of physical exercise
排除标准
- •Vascular intermittent claudication
- •Lumbar spinal stenosis in more than two levels
- •Previous low back surgery
- •Symptomatic lumbar disc herniation
- •Degenerative scoliosis with Cobbs angle 30 degrees or more
- •Degenerative spondylolisthesis grade 2 or more
- •Spondylolysis with spondylolisthesis
- •Recent osteoporotic fractures in the spine (last 6 month)
- •Severe symptomatic arthrosis in hip or knee
- •Locally advanced or metastatic cancer
- •Polyneuropathy recognized by neurography
- •Insufficient Norwegian language skills
结局指标
主要结局
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
时间窗: 6 months after index treatment
Oswestry Disability Index 2.0 (ODI) is the most commonly used condition-specific outcome measure for spinal disorders in general. The score ranges from 0 to 100, with a lower score indicating less severe pain and disability. It has been validated into Norwegian and tested for psychometric properties.
次要结局
- Patient reported back pain by Numeric Rating Scale (NRS)(Baseline and 2 years)
- The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)(2 years after index treatment)
- Patient reported leg pain by Numeric Rating Scale (NRS)(Baseline and 2 years)
- Walking capacity measured by six-minutes walk-test(Baseline and 6 months)
- Improvement in health-related quality of life(Baseline and 2 years)
- Improvement of walking and standing capacity measured with accelerometer(Baseline and 1 year)
- Fraction of patients crossing over from physical therapy to surgical decompression(1 year)