Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: Continuous Ablative Radiofrequency Vs. Chemical Denervation with Absolute Alcohol
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: Continuous Ablative Radiofrequency, Chemical Denervation with Absolute Alcohol.
- Кому может быть актуально
- Состояния в реестре: Osteoarthritis Knee, Chronic Pain. 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
- Бразилия
- 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
Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: a Randomized Clinical Trial of Continuous Ablative Radiofrequency Vs. Chemical Denervation with Absolute Alcohol
Обзор
This randomized clinical trial compares two minimally invasive treatments for knee osteoarthritis pain that has not responded to conventional therapies. The study evaluates the effectiveness and safety of continuous ablative radiofrequency, which uses heat energy to disrupt pain signals, and chemical denervation with absolute alcohol, which involves an injection to reduce pain transmission. Participants will be randomly assigned to one of the treatments, and their pain levels, mobility, and quality of life will be monitored over time to determine which method provides better pain relief.
Подробное описание
This randomized clinical trial compares continuous ablative radiofrequency and chemical denervation with absolute alcohol for pain relief in patients with knee osteoarthritis refractory to conventional treatments. Participants will be randomly assigned to one of the two procedures, with outcomes assessed based on pain reduction, functional improvement, quality of life, and safety. Follow-ups will be conducted for up to six months to evaluate the durability of pain relief, providing evidence to guide clinical management of chronic knee osteoarthritis pain.
Вмешательства
- Процедура Continuous Ablative Radiofrequency
Continuous ablative radiofrequency is a minimally invasive neuroablative procedure that targets the sensory genicular nerves to manage pain in knee osteoarthritis. Under ultrasound guidance, a radiofrequency probe is inserted percutaneously near the target nerves. The procedure delivers continuous thermal energy at 80°C for 120 seconds, creating a controlled lesion that disrupts pain signal transmission. This technique is distinct from pulsed radiofrequency, as it aims for permanent nerve ablati - Препарат Chemical Denervation with Absolute Alcohol
Chemical denervation with absolute alcohol is a minimally invasive neurolytic procedure targeting the sensory genicular nerves to manage chronic knee osteoarthritis pain. Under ultrasound guidance, a percutaneous injection of absolute alcohol 66% is administered near the targeted nerves. The neurolytic effect of alcohol induces axonal degeneration and Wallerian degeneration, leading to prolonged disruption of pain signal transmission. This intervention differs from radiofrequency ablation as it
Первичные конечные точки
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score [Срок оценки: 6 months]
Вторичные конечные точки (2)
- Numerical Rating Scale (NRS) for Pain [Срок оценки: 6 months]
- Short Form-36 Health Survey (SF-36) [Срок оценки: 6 months]
Критерии участия
Критерии включения
- Adults aged ≥ 18 years.
- Knee pain for more than 3 months.
- Clinical and imaging-confirmed diagnosis of knee osteoarthritis, based on X-ray, ultrasound, or magnetic resonance imaging (MRI).
Критерии исключения
- History of major joint interventions, such as previous knee surgery or arthroplasty.
- Severe joint effusion.
- Coagulation disorders or other clinical contraindications for the procedure.
- Uncontrolled comorbidities that increase procedural risk.
- Body mass index (BMI) > 35.
- Cognitive impairment that affects the ability to understand and respond to pain assessment instruments.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Бразилия · 1 центр
- Federal University of Sao Paulo - Hospital Sao Paulo, — São Paulo
Идентификаторы
NCT: NCT06858228 · 85243624.3.0000.5505