Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Compare the free walking speed in patients (6-minute walk test), before and after surgery
研究概览
简要总结
Low back pain is a leading cause of medical consultations in France and in other industrialized countries. Although spinal surgery is a recognized treatment, to date, its impact has only been assessed using subjective or declarative criteria. Yet, in many orthopaedic diseases, it has been shown that the evaluation of functional capacities, including walking speed, is particularly useful to study the impact of these diseases and their treatment. To date, no study has attempted to assess the impact of spinal surgery by evaluating 1) the functional capacities of patients and 2) spatio-temporal parameters of locomotion and joint dynamics. The investigators hypothesize that spinal surgery in patients with symptomatic lumbar spinal stenosis should lead to an improvement in quantifiable locomotion parameters, and in particular walking speed. Walking speed is a quantitative measurement, which could reflect the degree of functional impairment of the patient before and after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •more than 18 years old
- •who has provided verbal consent
- •with acquired arthritic lumbar spinal stenosis
- •eligible for surgery (pain > 3 months, resistant to medical treatment)
- •for whom the neurosurgeon has scheduled nerve decompression without osteosynthesis or instrumentation
- •able to walk ≥ 10 metres without help
排除标准
- •Adult under guardianship
- •Absence of health insurance cover
- •Pregnant or breast-feeding women
- •History of lumbar spinal surgery involving posterior or anterior arthrodesis
- •History of lumbar spinal surgery involving arthroplasty
- •History of lumbar spinal surgery within the previous 12 months
- •Locomotor disorders due to causes other than spine disease (orthopaedic, neurological, vascular, cardiac…) that could significantly affect walking speed
- •patients in whom the surgery could not be done or deferred (intolerance to the ventral decubitus position, infection…)
- •patients who had revisit surgery before M6 (with the exception of early revisit surgery during the first month post-intervention)
- •patients in whom osteosynthesis or the implantation of instruments was decided and done during the surgery
研究组 & 干预措施
Patients
干预措施: 3D analysis of locomotion and posture (Other)
Patients
干预措施: questionnaires (Other)
Patients
干预措施: Functional walk tests (Other)
Controls
干预措施: Functional walk tests (Other)
Controls
干预措施: 3D analysis of locomotion and posture (Other)
Controls
干预措施: questionnaires (Other)
结局指标
主要结局
Compare the free walking speed in patients (6-minute walk test), before and after surgery
时间窗: 2 weeks and 6 months
次要结局
未报告次要终点