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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Kartal
-
Istanbul, Kartal, Turquia (Türkiye), 34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in C-Reactive Protein Level
Prazo: 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.
|
Baseline and Week 4, immediately after completion of the 10th treatment session
|
|
Change in Functional Independence Measure Score
Prazo: 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
Prazo: Baseline and Week 4, immediately after completion of the 10th treatment session
|
Joint range of motion of joints affected by burn injury will be assessed using a universal goniometer.
Measurements will be recorded in degrees.
|
Baseline and Week 4, immediately after completion of the 10th treatment session
|
|
Change in Muscle Strength
Prazo: Baseline and Week 4, immediately after completion of the 10th treatment session
|
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.
|
Baseline and Week 4, immediately after completion of the 10th treatment session
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sümeyye Akçay, Fenerbahçe University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- KartalHospital
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .