Идёт набор NCT05963451
Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
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: No intervention.
- Кому может быть актуально
- Состояния в реестре: Chronic Low-back Pain. 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
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Assessing the Predictability of Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Обзор
The goal of this observational study is to better understand the role of the brain in chronic low back pain patients.
Подробное описание
Chronic pain affects millions of people worldwide, and the main cardinal sign of any arthritis condition is pain. Several arthritis conditions can cause chronic low back pain (CLBP).The mechanisms that contribute to CLBP are not yet fully understood, but considering the role of the brain in the context of chronic pain, it is only logical to investigate structural and functional brain properties in CLBP, in order to improve diagnosis and treatment of this condition.
Вмешательства
- Другое No intervention
No intervention will be given in our study since, the investigators are recruiting people who will receive already a facet thermal ablation.
Первичные конечные точки
- Change of Grey matter volume [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Blood-oxygen level dependent (BOLD) response [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Microstructural and connectivity properties of white matter tracts [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Brain's arteries system [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Brain's venous system [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
Вторичные конечные точки (12)
- Change of Pain Severity score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Pain Interference score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Pain Catastrophizing score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Neuropathic pain components score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Global function score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Anxiety score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Depression score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Fear of movement score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Functional disability score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Change of Insomnia severity score [Срок оценки: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)]
- Number of traumatic events [Срок оценки: Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment)]
- Patient Expectations score [Срок оценки: This will be acquired 1 week before their treatment]
Критерии участия
Критерии включения
- Low back pain (≥ 6 months) with or without pain radiating to the legs or radiating to the neck
- Positive medial branch blocks, suggesting that the pain originates from the lumbar facet joints
- Average pain intensity of ≥ 3/10 in the 24-hour period before the initial visit
- Pain primarily localized in the lower back
Критерии исключения
- Inadequate pain relief or relief of less than three months following selective thermoablation of medial lumbar branches by radiofrequency
- Neurological, cardiovascular, or pulmonary disorders
- Comorbid pain syndrome
- History of surgical intervention in the back
- A corticosteroid infiltration within the past year
- Pregnancy (current or planned during the course of the study)
- Contra-indication to Magnetic Resonance Imaging (MRI)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Канада · 1 центр
- Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS) — Sherbrooke
Идентификаторы
NCT: NCT05963451 · 2022-4293