Clinical trial NCT04381663: CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes
Official title: CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cervical Spinal Stenosis
Cervical Myelopathy
Keywords: Cervical Spinal Stenosis
Cervical Myelopathy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with degenerative cervical spine stenosis with or without myelopathy.

Brief 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.

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 .

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

Primary outcomes:
measure: 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
measure: 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.
measure: 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.
Secondary outcomes:
measure: Difference in daily physical activity
timeFrame: monitored for 7 consecutive days at visit 1 or 1 week before surgery and 6 months later at visit 2
measure: Difference in spinal cord gray and white matter areas
timeFrame: 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).
measure: Change in segmental quantitative muscle strength
timeFrame: approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
measure: Change in 25-foot walk test
timeFrame: approximate duration: 3 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
measure: Change in 6-minute walk test
timeFrame: approximate duration: 6 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
measure: Change in dynamic stability and range of motion during walking
timeFrame: approximate duration: 20 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
measure: Change in pain
timeFrame: approximate duration: 2 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
measure: Change in function
timeFrame: approximate duration: 13 min. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2
measure: Change in disability
timeFrame: approximate duration: 5 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
measure: Change in risk of falling
timeFrame: approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Annegret Mündermann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Cordula Netzer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Regina Schläger, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Martin Hardmeier, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: