An observational study in Cervical Spinal Stenosis and Cervical Myelopathy, sponsored by University Hospital, Basel, Switzerland. Enrolling by invitation at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by University Hospital, Basel, Switzerland · Observational
The study will consist of two parts:
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 .
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's planned enrollment of 60 is below the median of 116 across 152 observational studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Patients with degenerative cervical spine stenosis with or without myelopathy.
Exclusion Criteria:
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
Procedure: conservative treatment
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
Procedure: surgical treatment
conservative treatment for patients with cervical spine stenosis without myelopathy
surgical decompress the spinal canal in patients with moderate to severe degenerative cervical spine myelopathy
Difference in gait symmetry
The subjects will perform an instrumented gait analysis on an overground walkway with two embedded force plates
Time frame: 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
Balance performance will be assessed using the modified clinical test of sensory integration of balance (m-CTSIB) using the Biodex Balance System SD
Time frame: 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
Quantitative score of Motor evoked potentials (MEP) and Somato-sensory evoked potentials (SEP)
Time frame: 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 daily physical activity
daily physical activity will be objectively monitored for 7 consecutive days using the ActiGraph wGT3X-BT (ActiGraph Corp, Pensacola Florida, USA) worn around the hip
Time frame: 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
Participants will be investigated on the 3 Tesla (3T) whole body MRI research scanner using 2D-Averaged Magnetization Inversion Recovery Acquisitions (AMIRA) imaging
Time frame: 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
assessments of segmental muscle force via hand-held-dynamometry following the Treatment Research Initiative to Cure ALS (TRICALS) Protocol Isometric Strength Testing 2016 at each study visit
Time frame: 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
time of 25-foot walk test
Time frame: 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
distance of 6-minute walk test
Time frame: 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
Subjects will first complete overground walking trials in their own shoes at normal and fast walking speed while naming months backward in a 25-m hallway while gait CSS Study Protocol Version 2, 15.8.2019 Page 12 of 21 kinematics will be recorded using the RehaGait system. Afterwards, patients will be asked to walk over the force plates in the laboratory at their preferred walking speed while kinematic, kinetic and Electromyography (EMG) data will be recorded.
Time frame: 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
Numeric Pain Rate Scale (NPRS), a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
Time frame: 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
Modified Japanese Orthopaedic Association - Scoring System (mJOA) questionnaire, This scale consists of four domain scores motor dysfunction in the upper extremities, motor dysfunction in the lower extremities, sensory function in the upper extremities and bladder function. Each scale ranges from 0 to 7, 5, 3, and 3, respectively, with a total score of 0 to 18. The severity of myelopathy is defined as mild if the mJOA score is 15 or larger, moderate if the mJOA score ranges from 12 to 14 or severe if the mJOA score is less than 12
Time frame: 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
Neck Disability Index (NDI) questionnaire, a Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain. A score of 0-4 points means no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability, 35-50 points complete disability
Time frame: 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
The Berg Balance Scale (BBS) is a subjective measure for balance and risk of falling. Based on 14 items, vestibular function, balance ability, proprioception and muscle strength are assessed. The cut-off value for an elevated risk of falling is at 38 of 56 points. Older persons with a score of 45 of 56 points are able to ambulate safely and independently.
Time frame: approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
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University Hospital, Basel, Switzerland