Randomized Clinical Trial of Treatment for Spinal Stenosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Medical Outcomes Study 36-item Short Form Health Survey
研究概览
简要总结
Lumbar spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) is a condition that occurs frequently, particularly in the elderly. This condition can lead to significant pain and limit a person's ability to function. Moreover, doctors disagree about the best way to treat people with lumbar spinal stenosis.
In this study we will compare surgical treatment of lumbar spinal stenosis with nonsurgical treatment using physical therapy. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.
详细描述
Lumbar spinal stenosis is a frequently encountered condition, particularly in the elderly, which can lead to significant pain and functional limitations. The prevalence of this condition is growing as the population continues to age. Substantial controversy exists regarding the management of lumbar spinal stenosis. Surgery has traditionally been the treatment of choice, although physicians typically recommend a trial of nonsurgical care prior to surgery. The most effective means of nonsurgical treatment has not been identified, although a "standard" regimen has been developed.
There is presently no evidence in the literature regarding the relative effectiveness of surgical versus nonsurgical treatment of lumbar spinal stenosis, or the efficacy of the standard nonsurgical treatment approach. This randomized clinical trial will compare surgical decompression versus nonsurgical treatment (i.e., physical therapy) of lumbar spinal stenosis. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.
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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Imaging evidence of stenosis
- •Unable to walk more than 1/4 of a mile
- •No prior surgery for stenosis
- •Consents to surgery
- •Speaks English
排除标准
- •Presence of dementia or organic brain syndrome
- •Coronary artery disease, recent myocardial infarction, pulmonary or vascular disease
- •Spondylolisthesis (> 5 mm slippage)
- •Severe osteoporosis
- •Metastatic cancer
结局指标
主要结局
Medical Outcomes Study 36-item Short Form Health Survey
时间窗: Measured at Month 24
次要结局
- Beck Depression Inventory(Measured at Month 24)
- Oswestry Low Back Pain Disability Scale(Measured at Month 24)
- MODEMS questionnaires(Measured at Month 24)
- Physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill test(Measured at Month 24)