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Cervical Spinal StenosisNCT04381663

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

An observational study of Cervical Spinal Stenosis and Cervical Myelopathy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Spinal Stenosis, Cervical Myelopathy
What is being tested?
conservative treatment and surgical treatment
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 siteSwitzerland
Study dates
16 Sep 2019to Sep 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with degenerative cervical spine stenosis with or without myelopathy.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Inability to provide informed consent
  • Contraindications for recording of Motor evoked potentials (MEP)
  • Contraindications to safely undergo MRI

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site

  • Universitätsspital Basel

    Basel, 4031

Other trials in Switzerland

About this study

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.
Read the 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 .

Being tested
conservative treatment, surgical treatment
Keywords
Cervical Spinal Stenosis, Cervical Myelopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conservative treatmentProcedure or surgery

    conservative treatment for patients with cervical spine stenosis without myelopathy

  • surgical treatmentProcedure or surgery

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

Study groups in NCT04381663
Study groupRoleWhat they receive
conservative treatmentIn 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
Receives: Procedure: conservative treatment
surgical treatment (stenosis and myelopathy).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
Receives: Procedure: surgical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in gait symmetry

    The subjects will perform an instrumented gait analysis on an overground walkway with two embedded force plates

    Measured: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2

  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

    Measured: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

  3. Difference in neurophysiological outcome

    Quantitative score of Motor evoked potentials (MEP) and Somato-sensory evoked potentials (SEP)

    Measured: 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 (10)

  1. 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

    Measured: monitored for 7 consecutive days at visit 1 or 1 week before surgery and 6 months later at visit 2

  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

    Measured: 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).

  3. 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

    Measured: approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

  4. Change in 25-foot walk test

    time of 25-foot walk test

    Measured: approximate duration: 3 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

  5. Change in 6-minute walk test

    distance of 6-minute walk test

    Measured: approximate duration: 6 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

  6. 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.

    Measured: approximate duration: 20 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

  7. 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)

    Measured: approximate duration: 2 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

  8. 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

    Measured: approximate duration: 13 min. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2

  9. 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

    Measured: approximate duration: 5 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

  10. 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.

    Measured: approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study start16 Sep 2019
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381663
Sponsor's protocol ID
2019-01270;ch20Muendermann
Other IDs
2019
Status last verified
Dec 2024
First submitted
29 Apr 2020
Last updated
9 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Spinal Stenosis and Cervical Myelopathy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in gait symmetry (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04381663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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