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

University Hospital Basel

Status: Invitation-only

Conditions: Cervical Spinal Stenosis; Cervical Myelopathy

Treatments: Procedure: surgical treatment; Procedure: conservative treatment

Study type: Observational

Funder types: Other

Identifiers

NCT04381663

2019-01270 ch20Muendermann;

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

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

Treatment:

Procedure: conservative treatment

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

Treatment:

Procedure: surgical treatment