Single-Level TLIF: Post-Fusion Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change from baseline in Oswestry Disability Index [ODI] Score at 2-years
研究概览
简要总结
This investigation will assess how the timing and type of rehabilitation after a transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure. The efficacy of the procedure will be evaluated through patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure. These measures will be compared to the patients' baseline value.
详细描述
Patients will undergo transforaminal lumbar interbody fusion for degenerative pathology at the L4-5 vertebral level. They will be randomized to one of three postoperative rehabilitation groups. Group 1 will receive "structured early rehabilitation" beginning at 7 weeks. Group 2 will receive "Delayed rehabilitation" beginning at 13 weeks postoperatively. Group 3 will undergo "Self Rehabilitation" beginning at 7 weeks postoperatively. Groups 1 and 2 will undergo rehabilitation under the supervision of a certified physical therapist for 10 total weeks. Group 3 will undergo non-supervised rehabilitation for 10 total weeks, and will be given educational materials regarding which exercises to perform and at which intervals.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Single-level L4-L5 TLIF for degenerative pathology, including: radiculopathy, neurogenic claudication, intervertebral disc disease, facet joint disease, degenerative spondylolisthesis, degenerative myelopathy degenerative kyphosis and scoliosis ii. Back and/or leg pain iii. Failed at least 3 months of conservative treatment
排除标准
- •i. Older than 65 years of age ii. Prior spinal surgery excluding laminectomy/discectomy iii. Greater than Grade 2 spondylolisthesis iv. Greater than 10 degrees scoliosis v. Not worked for greater than 6 months or unemployed as a result of lumbar condition vi. History of spinal infection
结局指标
主要结局
Change from baseline in Oswestry Disability Index [ODI] Score at 2-years
时间窗: Baseline, 2-year postoperative
Oswestry Disability Index
次要结局
- Radiographic fusion(Baseline, 1-year postoperative)
- Change from baseline in Fear Avoidance Beliefs Metric at 2-years(Baseline, 2 year postoperative)
- Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years(Baseline, 2 year postoperative)
- Change from baseline in Short-Form 12 [SF-12] Scores at 2-years(Baseline, 2 year postoperative)
- Change from baseline in Pain Neurophysiology Metric at 2-years(Baseline, 2 year postoperative)
- Change from baseline in walking ability at 2-years(Baseline, 2 years postoperative)
- Change from baseline in walking speed at 2-years(Baseline, 2 years postoperative)
- Change from baseline in Pain Catastrophization Metric at 2-years(Baseline, 2 year postoperative)
- Change from baseline PROMIS Physical Function Scores at 2-years(Baseline, 2 year postoperative)
研究者
Carla Edwards
Clinical Research Manger
Rush University Medical Center