CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes (NCT04381663) | Clinical Trial Compass
By InvitationNot Applicable
CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes
Switzerland60 participantsStarted 2019-09-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in gait symmetry
Timeframe: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2
2
Change in balance performance
Timeframe: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
3
Difference in neurophysiological outcome
Timeframe: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.