Focused Spinal Stenosis Rehabilitation Program vs. Generic Williams Flexion Protocol
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in functional ability
研究概览
简要总结
Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain, as well as by weakness precipitated by walking and prolonged standing. Self-management options include physical therapy, which includes exercise as a core component for improving the flexibility and mobility of the spine and hips. A Williams flexion protocol has historically been used to treat low-back pain following degenerative changes to the posterior elements of the lumbar spine. However, few studies have been done to validate the efficacy of this protocol. A more focused treatment protocol may be more efficacious. Patients in this study will be randomized to receive either the generic physical therapy protocol (15 sessions) or the focused rehabilitation program (5 sessions). The sessions will take place over the course of 6 months. Outcomes will be assessed using validated questionnaires and physical function tests.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar spinal stenosis with neurogenic claudication
- •Symptoms present for at least 3 months
- •Moderate to severe acquired or congenital LSS based on radiological evaluation
- •Lumbar MRI obtained within the past 12 months prior to initial physical therapy visit
- •40 years of age or older
- •Body mass index less than or equal to 35
- •Can tolerate a 6-min treadmill test
- •Willing to comply with home exercises as prescribed
排除标准
- •Acute disc herniation
- •Grade 3 or greater spondylolisthesis
- •Rheumatoid or autoimmune conditions (e.g., ankylosing spondylitis)
- •Active spinal compression fractures
- •Knee surgery in the previous 6 months (e.g., total knee arthroplasty)
- •Previous spinal fusion
- •Absence of pedal pulses
- •Inflammation/infectious process
- •Myelopathy
- •Psychiatric disorder preventing informed consent or participation in assigned physical therapy sessions
- •Patients with pending litigation or workers compensation
研究组 & 干预措施
Individualized
干预措施: Focused spinal stenosis rehabilitation (Procedure)
Standard
干预措施: Williams flexion protocol (Procedure)
结局指标
主要结局
Change in functional ability
时间窗: Up to 1 year after initial physical therapy visit
Change in functional ability will be assessed using the Oswestry Disability Index. The minimum clinically important difference of the ODI has been documented in the literature as a 13-point change.
次要结局
- Pain(Up to 1 year after initial physical therapy visit)
- Quality of life(Up to 1 year after initial physical therapy visit)
- Tolerance to exercise(Up to 1 year after initial physical therapy visit)
- Physical ability(Up to 1 year after initial physical therapy visit)