Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration. Randomized and Comparative Study: Kyphosis Reeducation Versus Spinal Mobility Reeducation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- maximal walking distance
研究概览
简要总结
In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The study assume that the spinal mobility reeducation will reduce the incidence of pain recurrences compared with the classic kyphosis reeducation.
详细描述
The standard treatment of lumbar spinal stenosis is the lumbar canal recalibration surgery which presents co-morbidity factors and risks of post-operative complications. The non-invasive methods are a good alternative compared with the surgery : the patients medically treated present few damages and the results of the postponed surgery are equivalent to the immediate surgery. That is why a non-surgical treatment is proposed in first intention to the patients with mild or moderate symptoms : this treatment associates an epidural infiltration and a kyphosis reeducation.
Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The benefits of the infiltration are lost three months after this one in 80 % of the cases. A return to physical activity and a restored spinal mobility would improve the duration of the infiltration effect. The objective is then to compare the efficiency of a spinal mobility reeducation program versus a kyphosis reeducation program in patients with acquired and central lumbar spinal stenosis. It is a prospective, monocentric, randomized, superiority and parallel-group study :
- group C (control group) : kyphosis reeducation + patient education + auto-reeducation at home,
- group M (test group) : spinal mobility reeducation + patient education + auto-reeducation at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 50 years,
- •central, acquired and multi-staged lumbar spinal stenosis,
- •pain since at least three months,
- •radicular pains higher than the lumbar pains,
- •walking distance < 1000 m,
- •oral consent.
排除标准
- •intercurrent pathology limiting the walking distance (arteriopathy, cardio-respiratory insufficiency, disabling arthrosis affecting the lower limbs...),
- •history of spinal surgery for lumbar spinal stenosis,
- •extended lumbar arthrodesis (equal to or greater than 2 levels),
- •monosegmental and degenerative spondylolisthesis,
- •foraminal stenosis,
- •motor deficit of the lower limbs or Cauda equina syndrome ("Cauda equina" syndrome (CES) is a serious neurologic condition in which damage to the cauda equina causes acute loss of function of the lumbar plexus, (nerve roots) of the spinal canal below the termination (conus medullaris) of the spinal cord),
- •bleeding disorders or allergies contraindicating the epidural infiltration.
结局指标
主要结局
maximal walking distance
时间窗: the 90 days visit
: ratio between the maximal walking distance at the 90 days visit and the maximal walking distance at the Day 4 in percent. Walking on a plane road, 70 m in length, without obstacle and with markings every 10 meters (total length : not more than 2 km).
次要结局
- evaluation of the radicular pain(Day 365)
- score of "Douleur Neuropathique 4" (DN4 - neuropathy)(Day 365)
- score Medical Outcomes Study Short-Form General Health Survey 12 (health status)(Day 365)
- maximal walking distance(Day 365)
- compliance with the auto-reeducation at home(Day 365)
- evaluation of the lumbar pain(Day 365)
- evaluation scales(Day 365)
- Score of Japanese Orthopaedic Association (llumbar radiculopathy)(Day 365)