Randomized Clinical Trial of Supervised Physical Therapy Versus Unsupervised Home Exercise in Patients Recovering After Surgery for Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Oswestry disability index
研究概览
简要总结
This is a randomized controlled trial evaluation effect of postoperative rehabilitation after surgery for lumbar disc herniation.
The primary aim of this study is to evaluate the effect of unsupervised home exercises compared to supervised physical rehabilitation.
Secondary aims of this study are to determine if there is a difference in cost-effectiveness in patients undergoing supervised physical rehabilitation in patients after surgery for lumbar disc herniation compared to unsupervised home exercises.
详细描述
Objectives:
The primary aim of this thesis is to determine whether unsupervised home exercises are not inferior to supervised physical rehabilitation in patients after surgery for lumbar disc herniation.
Ho: There is a difference in improvement in outcomes, as measured by the change in Oswestry Disability Index at six months post-operative compared to baseline, between patients undergoing supervised physical rehabilitation in patients after surgery for lumbar disc herniation compared to unsupervised home exercises.
H1: There is no difference in improvement in outcomes, as measured by the change in Oswestry Disability Index at six months post-operative compared to baseline, between patients undergoing supervised physical rehabilitation in patients after surgery for lumbar disc herniation compared to unsupervised home exercises.
Secondary aims of this study are to determine if there is a difference in cost-effectiveness in patients undergoing supervised physical rehabilitation in patients after surgery for lumbar disc herniation compared to unsupervised home exercises. Differences in effectiveness will be determined using Quality Adjusted Life Years (QALYs) calculated from the EQ-5D and the SF-6D. Both these health state utility values will be used, as studies in low back patients have shown a marked difference in the calculation of QALYs when one or the other is used (9-11).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Clinical symptoms and concordant MRI findings of a lumbar disc herniation from L1 to S1 with indications for discectomy surgery, assessed by an experienced spinal surgeon
- •Age 18-65 years
排除标准
- •History of previous spine surgery or disease (eg. spinal fracture, scoliosis or stenosis)
- •General contra-indication for spine surgery
- •Diagnosis of psychiatric disorder
- •Current malignant disease
- •Hematologic disease
- •Major surgical procedures within 12 months (eg. collum femoris fracture)
- •Chronic, generalized connective tissue disorders or chronic, non-specific pain disorders (fibromyalgia, whiplash, etc.)
研究组 & 干预措施
Standard municipal rehabilitation
Standard care with postoperative rehabilitation at the municipal facility.
No referral for rehabilitation
No referral for supervised postoperative rehabilitation. Only standard information booklet and advice during hospitalization.
干预措施: No referral for rehabilitation (Other)
结局指标
主要结局
Oswestry disability index
时间窗: 6 month postoperative.
Functional status questionaire
次要结局
- SF-6D(12 month postoperative)
- EuroQOL -5D(12 month postoperative)
研究者
Rune Tendal Paulsen
Principal investigator
Spine Centre of Southern Denmark