Меню
Идёт набор NCT05310578

Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression

— Наблюдательное Cervical Radiculopathy

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: Posterior cervical foraminotomy (with our without laminectomy).
Кому может быть актуально
Состояния в реестре: Cervical Radiculopathy. Базовые параметры: 18 лет — 75 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
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression: a Prospective Multicenter Observational Study with a 2 Year Follow-up.

Обзор

Compression on structures, as spinal nerves, in the cervical spine can cause cervical radiculopathy which leads to pain, disability, and reduced quality of life for the affected individual. Cervical foraminotomy with our without laminectomy are common posterior decompression surgical techniques for treating cervical radiculopathy. There is a lack of knowledge regarding function in patients with cervical radiculopathy after posterior cervical decompression. The aim with this study is to study pain, function, psychosocial factors, and health related quality of life after posterior cervical decompression in patients with cervical radiculopathy. This is a prospective multicenter longitudinal observational cohort study with follow-up at three, 12- and 24 months postoperative. A total of 154 individuals scheduled to undergo foraminotomy with our without laminectomy due to cervical radiculopathy will be included. Primary outcome is neck-specific function measured with the Neck Disability Index. Data will be collected preoperatively and at three, 12 and 24 months with electronic questionnaire.

Вмешательства

  • Процедура Posterior cervical foraminotomy (with our without laminectomy)
    The aim of surgery is to decrease the compression of the affected nerve. In posterior cervical foraminotomy, the foramina is expanded to create more space and with posterior cervical laminectomy the lamina is removed to create space mainly for the spinal cord.

Первичные конечные точки

  • Neck DisabiIity Index; 0-100% (0% = No disability) [Срок оценки: Change from baseline to 24 months postoperatively]
Вторичные конечные точки (12)
  • Numeric Rating Scale; 0-10 (0 = No pain/dizziness) [Срок оценки: Change from baseline to 24 months postoperatively]
  • Frequency of symptoms (5-grade scale from never to always) [Срок оценки: Change from baseline to 24 months postoperatively]
  • Specific questions regarding headache and dizziness [Срок оценки: Change from baseline to 24 months postoperatively]
  • Dizziness Handicap Inventory Scale; 0-100 (0 = no disability) [Срок оценки: Change from baseline to 24 months postoperatively]
  • Short Form Headache Impact test; 36-78 (36 = no impact) [Срок оценки: Change from baseline to 24 months postoperatively]
  • Core outcome measure Index for neck; 0-10 (0 = good function) [Срок оценки: Change from baseline to 24 months postoperatively]
  • Patient derived Modified Japanese Orthopeadic Association; 0-18 (18 = normal/no myelopathy). [Срок оценки: Change from baseline to 24 months postoperatively]
  • Odom; 7-point scale (restored/much better to much worse) [Срок оценки: Change from baseline to 24 months postoperatively]
  • Global rating of change scale; 11 points scale (-5 - 5 where 5 indicates restored). [Срок оценки: Change from baseline to 24 months postoperatively]
  • Fear Avoidance Beliefs Questionnaire; 0-96 (0 = no fear). [Срок оценки: Change from baseline to 24 months postoperatively]
  • Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing) [Срок оценки: Change from baseline to 24 months postoperatively]
  • Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy) [Срок оценки: Change from baseline to 24 months postoperatively]

Критерии участия

Критерии включения

  • Cervical radiculopathy, confirmed by MRI images (or alternative neuroradiological imaging if MRI contraindicated) compatible with clinical findings of nerve root compression (neurological examination performed by a neurosurgeon/orthopedic surgeon)
  • Posterior cervical decompression as foraminotomy with our without laminectomy
  • At least 3 months of persistent arm pain
  • Age 18-75 years

Критерии исключения

  • Nurick score 2 or more (to exclude individuals with moderate to high myelopathy)
  • Previous surgery of cervical spine
  • Previous fracture or dislocation of the cervical spine
  • Malignancy or benign spinal tumor (eg, neuromas)
  • Spinal infection
  • Previous spondylodiscitis
  • Servere mental disorder
  • Known alcohol or drug abuse
  • Lack of ability to write/comprehend/express oneself in Swedish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 3 центра
  • Neuro-ortopediska kliniken — Jönköping
  • Neurosurgery clinic — Linköping
  • Ryggkirurgiskt Centrum — Stockholm

Идентификаторы

NCT: NCT05310578 · CR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗