CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes

CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes

Sponsors

Lead Sponsor: University Hospital, Basel, Switzerland

Source University Hospital, Basel, Switzerland
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 .

Overall Status Enrolling by invitation
Start Date September 16, 2019
Completion Date September 15, 2022
Primary Completion Date March 15, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Difference in gait symmetry 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 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 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
Measure Time Frame
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
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 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 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 pain 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 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 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.
Enrollment 60
Condition
Intervention

Intervention Type: Procedure

Intervention Name: conservative treatment

Description: conservative treatment for patients with cervical spine stenosis without myelopathy

Arm Group Label: conservative treatment

Intervention Type: Procedure

Intervention Name: surgical treatment

Description: surgical decompress the spinal canal in patients with moderate to severe degenerative cervical spine myelopathy

Arm Group Label: surgical treatment (stenosis and myelopathy).

Eligibility

Sampling Method: Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Overall Official
Location
Facility: Universitätsspital Basel
Location Countries

Switzerland

Verification Date

April 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: conservative treatment

Description: In study A this group will be treated conservatively (stenosis). Study B is a single centre longitudinal study where the same patient groups will be followed up during the course of their treatment

Label: surgical treatment (stenosis and myelopathy).

Description: In study A this group 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

Study Design Info

Observational Model: Cohort

Time Perspective: Other

Source: ClinicalTrials.gov