Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
The aim is to study if pre-surgery physiotherapy improves function, pain and health in patients with specific low back pain scheduled for surgery. Patients are followed over a two year period. A secondary aim is to study what factors predict short and long term outcomes.
详细描述
The design is a randomized controlled trial, where patients are allocated either to pre-surgery physiotherapy or waiting-list when scheduled for surgery due to specific low back pain (spinal stenosis, disc herniation, spondylolisthesis, disc degenerative disease (DDD)).
The patients are scheduled for surgery due to specific low back pain diagnosis and randomized to either pre-surgery physiotherapy or waiting-list group. Clinical measurement and treatment-classification is done before and after intervention.
Pre-surgery intervention:
Physiotherapy guided intervention twice a week for nine weeks. The program includes:
- Active physiotherapy according to a treatment based classification
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are scheduled for surgery due to following diagnoses;
- •Disc herniation,
- •Spinal stenosis,
- •Spondylolisthesis,
- •Degenerative disc disease.
- •Fluent in Swedish.
排除标准
- •need of acute surgery
- •other severe diagnoses.
研究组 & 干预措施
Pre-surgery physiotherapy
Twice a week, in 9 weeks
干预措施: Pre-surgery physiotherapy (Other)
Waiting-list
Standard information by the orthopedic surgeon
干预措施: Waiting-list (Other)
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
次要结局
- Visual analog scale for leg pain(Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
- Visual analog scale for lumbar pain(Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
- Fear avoidance belief questionnaire (FABQ)(Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
- Anxiety, depression (HADS)(Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
- Health (SF-36, EQ-5D)(Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
- Self efficacy (SES)(Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
- Workability, (WAI)(Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
研究者
Birgitta Oberg
Professor
Linkoeping University