CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: conservative treatment, surgical treatment.
- Who it may be relevant to
- Registry conditions: Cervical Spinal Stenosis, Cervical Myelopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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 .
Interventions
- Procedure conservative treatment
conservative treatment for patients with cervical spine stenosis without myelopathy - Procedure surgical treatment
surgical decompress the spinal canal in patients with moderate to severe degenerative cervical spine myelopathy
Primary outcome measures
- Difference in gait symmetry [Time frame: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2]
- Change in balance performance [Time frame: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.]
- Difference in neurophysiological outcome [Time frame: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.]
Secondary outcome measures (10)
- Difference in daily physical activity [Time frame: monitored for 7 consecutive days at visit 1 or 1 week before surgery and 6 months later at visit 2]
- Difference in spinal cord gray and white matter areas [Time frame: 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 [Time frame: 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 25-foot walk test [Time frame: 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 6-minute walk test [Time frame: 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 [Time frame: 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 pain [Time frame: approximate duration: 2 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.]
- Change in function [Time frame: 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 [Time frame: 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 risk of falling [Time frame: approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Universitätsspital Basel — Basel
Identifiers
NCT: NCT04381663 · 2019-01270;ch20Muendermann