Self-rehabilitation At Home After LumbaR Arthrodesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change of lumbar pain
研究概览
简要总结
Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist.
The investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).
详细描述
Due to population aging, lumbar arthrodesis is becoming more frequent in general population. At the same time, those patients need early rehabilitation, even if they do not experiment any motor disability after surgery : it has been showed that early rehabilitation improves lumbar pain thanks to muscle strengthening.
The design of the study is prospective,monocentric, controlled and randomized. This study compares progressive self-rehabilitation at home after lumbar arthrodesis, explained to the patient by a physiotherapist during his or her stay at the hospital and started right after surgery, versus rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment).
The primary outcome is decrease of lumbar pain at 6 weeks and 3 months after surgery. The secondary outcomes are improvement of functional abilities and improvement of pelvis and limbs ranges of motion.
Patients of both groups will be followed by surgeon and physiotherapist at 6 weeks and 3 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar pain and/or nerve root pain and/or limp without any motor deficiency of the limbs, before and/or after surgery (if any motor deficiency occurs after surgery, it will be a secondary exclusion criteria)
- •Surgery for posterolateral lumbar arthrodesis, from a degenerative etiology, from 1 to 3 lumbar levels (one level means one inter-somatic space)
- •Surgery indication after optimal medical treatment, including appropriate pain medicine, and fail of medical treatment for reducing lumbar pain and/or nerve root pain and/or limp
- •Return home possible after surgery
- •After signing consent during pre-operative visit with the surgeon
排除标准
- •People under 18 years-old
- •Pregnant or breast-feeding women
- •Psychiatric and/or neurodegenerative comorbidity
- •Motor deficiency of the limbs before and/or after surgery
- •Iliac extension of arthrodesis
- •Any postoperative complication lengthening stay at hospital
- •Medical contraindication for early rehabilitation
结局指标
主要结局
Change of lumbar pain
时间窗: At 6 weeks and 3 months after surgery
Improvement of Short Form 36 score (SF-36) Unit : number of points Each item is graded on a scale of 0 to 100, with 0 and 100 serving as the lowest and highest possible scores. A higher number indicates that the subject is in better overall health.
次要结局
- Improvement of ranges of motion - Ely test(At 6 weeks and 3 months after surgery)
- Improvement of ranges of motion - Straight Leg Test(At 6 weeks and 3 months after surgery)
- Improvement of ranges of motion - Schober test(At 6 weeks and 3 months after surgery)
- Improvement of functional abilities(At 6 weeks and 3 months after surgery)