Non-Invasive Vagus Nerve Stimulation in Patients With Acute Burn Injuries

Официальное название

The Effects of Non-Invasive Vagus Nerve Stimulation on Inflammatory Response and Functional Recovery in Patients With Acute Burn Injuries

Обзор

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.

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.

Вмешательства

• Устройство Non-Invasive Auricular Vagus Nerve Stimulation
  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.
• Другое Conventional Physiotherapy
  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.

Первичные конечные точки

• Change in C-Reactive Protein Level [Срок оценки: Baseline and Week 4, immediately after completion of the 10th treatment session]
• Change in Functional Independence Measure Score [Срок оценки: Baseline and Week 4, immediately after completion of the 10th treatment session]
• Change in Joint Range of Motion [Срок оценки: Baseline and Week 4, immediately after completion of the 10th treatment session]
• Change in Muscle Strength [Срок оценки: Baseline and Week 4, immediately after completion of the 10th treatment session]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Turkey (Türkiye) · 1 центр

• Kartal Dr. Lütfi Kırdar City Hospital Burn Unit — Istanbul

Идентификаторы

NCT: NCT07574580 · KartalHospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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