Non-Invasive Vagus Nerve Stimulation in Patients With Acute Burn Injuries
The Effects of Non-Invasive Vagus Nerve Stimulation on Inflammatory Response and Functional Recovery in Patients With Acute Burn Injuries
This randomized controlled study will investigate the effects of non-invasive vagus nerve stimulation on inflammatory response and functional recovery in adults with acute burn injuries. Participants will be adults aged 18 to 65 years with second- or third-degree burns involving 5% to 30% of total body surface area and who are enrolled within the first 72 hours after hospitalization.
Participants will be randomly assigned to one of two groups. The intervention group will receive non-invasive auricular vagus nerve stimulation in addition to conventional physiotherapy. The control group will receive conventional physiotherapy only. The stimulation will be applied through surface electrodes placed on the auricular region of the ear for 20 minutes per session, for a total of 10 sessions.
The main outcomes will be inflammatory response, assessed by C-reactive protein levels, and functional recovery, assessed by the Functional Independence Measure. Assessments will be performed before the intervention and after completion of the 10 treatment sessions.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Burn injuries may trigger a systemic inflammatory response and lead to impaired functional recovery. Non-invasive auricular vagus nerve stimulation may modulate autonomic and inflammatory pathways and may support recovery in patients with acute burn injuries.
This randomized controlled study will be conducted in adults with acute second- or third-degree burn injuries involving 5% to 30% of total body surface area. Eligible participants will be enrolled within the first 72 hours after hospitalization and randomly assigned to an intervention group or a control group.
The intervention group will receive non-invasive auricular vagus nerve stimulation in addition to conventional physiotherapy. Stimulation will be delivered using surface electrodes placed on the auricular region of the ear. Each session will last 20 minutes, and the intervention will be administered for a total of 10 sessions. The control group will receive conventional physiotherapy only. Conventional physiotherapy will be planned according to individual clinical needs and may include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor activities, active range of motion exercises, and neurodevelopmental treatment approaches.
Outcome assessments will be performed before treatment and after completion of the 10 treatment sessions. Inflammatory response will be evaluated using C-reactive protein levels obtained from routine blood test records. Functional recovery will be evaluated using the Functional Independence Measure, joint range of motion, and muscle strength assessments.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Kartal
-
Istanbul, Kartal, Турция (Туркие), 34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Aged 18 to 65 years
- Diagnosed with second- or third-degree burn injury involving 5% to 30% of total body surface area
- Enrolled within the first 72 hours after hospitalization due to burn injury
- Stable vital signs and general clinical condition suitable for the intervention
- Able to read and understand Turkish and communicate adequately
- Provided written informed consent
Exclusion Criteria:
- Severe burn injury in the head and neck region preventing application of the device to the auricular vagus nerve area
- Chronic pulmonary and/or cardiac disease
- Heart rate below 60 beats per minute
- History of epilepsy, severe psychiatric disease, or neurological disorder
- Presence of a cardiac pacemaker or implantable electronic device
- Autoimmune or chronic systemic inflammatory disease
- Cognitive impairment preventing adherence to the study protocol
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy
Participants in this group will receive non-invasive auricular vagus nerve stimulation in addition to conventional physiotherapy.
Stimulation will be applied through surface electrodes placed on the auricular region of the ear for 20 minutes per session, for a total of 10 sessions.
Conventional physiotherapy will be provided according to individual clinical needs.
|
Non-invasive auricular vagus nerve stimulation will be applied using surface electrodes placed on the auricular region of the ear.
Each session will last 20 minutes, and the intervention will be administered for a total of 10 sessions.
Stimulation intensity will be adjusted according to the participant's sensory threshold and tolerance.
Conventional physiotherapy will be planned according to individual clinical needs and may include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor activities, active range of motion exercises, and neurodevelopmental treatment approaches.
|
|
Активный компаратор: Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy only.
Physiotherapy will be planned according to individual clinical needs and may include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor activities, active range of motion exercises, and active range of motion exercises.
|
Conventional physiotherapy will be planned according to individual clinical needs and may include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor activities, active range of motion exercises, and neurodevelopmental treatment approaches.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in C-Reactive Protein Level
Временное ограничение: Baseline and Week 4, immediately after completion of the 10th treatment session
|
C-reactive protein level will be used to assess systemic inflammatory response.
CRP values will be obtained from routine blood test records and recorded in mg/L.
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Baseline and Week 4, immediately after completion of the 10th treatment session
|
|
Change in Functional Independence Measure Score
Временное ограничение: Baseline and Week 4, immediately after completion of the 10th treatment session
|
Functional recovery will be assessed using the Functional Independence Measure.
The scale evaluates motor and cognitive independence in activities of daily living.
Total scores range from 18 to 126, with higher scores indicating greater functional independence.
|
Baseline and Week 4, immediately after completion of the 10th treatment session
|
|
Change in Joint Range of Motion
Временное ограничение: Baseline and Week 4, immediately after completion of the 10th treatment session
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Joint range of motion of joints affected by burn injury will be assessed using a universal goniometer.
Measurements will be recorded in degrees.
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Baseline and Week 4, immediately after completion of the 10th treatment session
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Change in Muscle Strength
Временное ограничение: Baseline and Week 4, immediately after completion of the 10th treatment session
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Muscle strength will be assessed using manual muscle testing.
Relevant muscle groups affected by burn injury will be evaluated, with higher grades indicating greater muscle strength.
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Baseline and Week 4, immediately after completion of the 10th treatment session
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Sümeyye Akçay, Fenerbahce University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- KartalHospital
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .