CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in neurophysiological outcome
研究概览
简要总结
The study will consist of two parts:
- In Study A, objectively assessed physical activity, gait, balance, range of movement of specific joints during walking and neurophysiological findings between patients with cervical spine stenosis (CSS) without myelopathy who will be treated conservatively and patients with stenosis and signs of myelopathy who are candidates for surgical Treatment will be compared.
- In Study B, the 6-month changes in the same outcomes in patients treated conservatively (from the first specialist consultation until 6 months later) and in patients treated surgically (preoperative day and 6-month post-operatively) will be quantified.
详细描述
Study A is a single centre cross-sectional study with two study groups, one that will be treated conservatively (stenosis) and one that will be treated surgically (stenosis and myelopathy).
Study B is a single centre longitudinal study where the same patient groups will be followed up during the course of their treatment.
Clinical, radiological, biomechanical (kinematic and electromyographic), neurological and neurophysiological data will be collected. Differences in and the relationship between the clinical, radiological, biomechanical, neurological and neurophysiological data will be determined .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age > 18 years
- •Diagnosis of degenerative cervical spine stenosis defined by MRI (stenosis grade 2 or grade 3
- •Local clinical symptoms due to degenerative changes of the cervical vertebral column with or without clinically defined myelopathy
排除标准
- •Stenosis after trauma or neoplasm
- •Prior decompressive surgery
- •Previous spine or extremity surgery with a consequent sensorimotor impairment
- •Other pathologies than cervical spine stenosis causing gait disturbance
- •BMI > 35 kg/m2
- •Use of walking aids
- •Inability to provide informed consent
- •Contraindications for recording of Motor evoked potentials (MEP)
- •Contraindications to safely undergo MRI
结局指标
主要结局
Difference in neurophysiological outcome
时间窗: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
Quantitative score of Motor evoked potentials (MEP) and Somato-sensory evoked potentials (SEP)
Difference in gait symmetry
时间窗: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2
The subjects will perform an instrumented gait analysis on an overground walkway with two embedded force plates
Change in balance performance
时间窗: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
Balance performance will be assessed using the modified clinical test of sensory integration of balance (m-CTSIB) using the Biodex Balance System SD
次要结局
- Difference in daily physical activity(monitored for 7 consecutive days at visit 1 or 1 week before surgery and 6 months later at visit 2)
- Change in 6-minute walk test(approximate duration: 6 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.)
- Change in dynamic stability and range of motion during walking(approximate duration: 20 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.)
- Change in 25-foot walk test(approximate duration: 3 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.)
- Change in risk of falling(approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.)
- Difference in spinal cord gray and white matter areas(approximate duration of the scan: 30. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2 (Measurement at visit 2 only in patients with cervical spine stenosis treated conservatively).)
- Change in segmental quantitative muscle strength(approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.)
- Change in function(approximate duration: 13 min. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2)
- Change in disability(approximate duration: 5 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.)
- Change in pain(approximate duration: 2 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.)