Examining the Effectiveness of a Post-operative Rehabilitation Program Emphasizing Restoration of Multifidus Muscle Function for Individuals Undergoing Lumbar Discectomy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Modified Oswestry disability index
研究概览
简要总结
The proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery. The study will compare two different post-operative physical therapy programs (general strengthening or general + specific strengthening). Both groups will begin treatment 2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8 weeks with a treatment program emphasizing exercises shown to activate the large trunk muscles without imposing potentially harmful compression or shear forces. The general + specific strengthening group will also receive exercises shown to isolate activation of the deep trunk muscles, in particular the multifidus, with training augmented by the use of diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years old
- •Diagnosis of LDH based on imaging (MRI or CT scan) of the lumbar spine with concurring clinical examination findings (based on the judgment of the attending neurosurgeon)
- •Appropriate surgical candidate based on the opinion of the attending spine surgeon, and scheduled for single-level lumbar discectomy (open or micro-discectomy).
- •Able to attend weekly treatment sessions.
排除标准
- •Prior surgery to the lumbar spine
- •Spondylolytic or degenerative spondylolisthesis present on pre-surgical imaging
- •Unable to speak and understand English
- •Peri- or post-operative complication (infection, nerve injury, dural tear, vascular injury, etc.) that would limit or delay the ability to participate in post-operative rehabilitation.
- •Multi-level surgery or the use of instrumentation during surgery (i.e., lumbar fusion)
结局指标
主要结局
Modified Oswestry disability index
时间窗: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
次要结局
- Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging(preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months)
研究者
Julie Fritz
Associate Professor
University of Utah