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

Last updated: December 6, 2024
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Enrolling

Phase

N/A

Condition

Spinal Stenosis

Spinal Cord Disorders

Spondylolisthesis

Treatment

conservative treatment

surgical treatment

Clinical Study ID

NCT04381663
2019-01270;ch20Muendermann
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years

  • Diagnosis of degenerative cervical spine stenosis defined by MRI (stenosis grade 2or grade 3

  • Local clinical symptoms due to degenerative changes of the cervical vertebral columnwith or without clinically defined myelopathy

Exclusion

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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: conservative treatment
Phase:
Study Start date:
September 16, 2019
Estimated Completion Date:
September 30, 2025

Study 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 .

Connect with a study center

  • Universitätsspital Basel

    Basel, 4031
    Switzerland

    Site Not Available

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