Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recurrence rate or reherniation/restenosis by means of MRI results
研究概览
简要总结
The aim of the study is to assess the benefit of wearing a lumbar orthosis after surgery for spinal stenosis. It will be evaluated if a post-surgery immobilization for 6 weeks with a lumbar orthosis reduces early recurrence, increases walking distance, decreases significantly faster pain and pain medication after surgery
详细描述
Spinal stenosis and orthoses The study situation in this regard is very poor, high-quality level 1 studies are not available.
A study by Prateepavanich et al. from 2001 shows advantages in the therapy with lumbar orthoses in neurogenic spinal claudication in the context of conservative therapy (9). Regarding postoperative prescription, expert opinions have long diverged (10). Nevertheless, in a survey of North American spine surgeons, over 60% reported prescribing an orthosis postoperatively (11).
2 Aim of the study
The aim of this study is to show that patients after surgical decompression for lumbar spinal stenosis and patients after surgical sequestrectomy benefit from temporary postoperative immobilization using a lumbar orthosis.
To show that postoperative therapy with a lumbar orthosis prolongs walking distance and reduces early recurrence.
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Decompression with hemi-/ partial laminectomy, one. Laminectomy, and foraminotomy. Flavectomy with undercutting due to uni-and multi-segmental spinal stenosis.
- •Age 20-80 years
- •Pre-operative walking distance at least 100m
- •Consent form signed by the patient
排除标准
- •Fusion surgery or recurrent surgery
- •Tumors of the spine
- •Cervical spinal stenosis or myelopathy
- •Rheumatoid arthritis or similar autoimmune disease
- •Infection - request for a pension
- •Dyspnea due to heart failure with limited walking distance
- •Peripheral Arterial Occlusive Disease (PAOD)-
结局指标
主要结局
Recurrence rate or reherniation/restenosis by means of MRI results
时间窗: at 104 weeks
symptomatic reduction of Walking distance
次要结局
- Pain and Disability Index(At 0, 2, 6, 12, 24, 52 and 104 weeks)