CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: conservative treatment, surgical treatment.
- Кому может быть актуально
- Состояния в реестре: Cervical Spinal Stenosis, Cervical Myelopathy. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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 .
Вмешательства
- Процедура conservative treatment
conservative treatment for patients with cervical spine stenosis without myelopathy - Процедура surgical treatment
surgical decompress the spinal canal in patients with moderate to severe degenerative cervical spine myelopathy
Первичные конечные точки
- Difference in gait symmetry [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.]
Вторичные конечные точки (10)
- Difference in daily physical activity [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 1 центр
- Universitätsspital Basel — Basel
Идентификаторы
NCT: NCT04381663 · 2019-01270;ch20Muendermann