An interventional study of Non-Invasive Auricular Vagus Nerve Stimulation and Conventional Physiotherapy in Acute Burns, sponsored by Fenerbahce University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Fenerbahce University · Not applicable, Interventional, and Treatment
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.
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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →Fenerbahce University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Non-Invasive Auricular Vagus Nerve Stimulation · Other: 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.
Other: Conventional Physiotherapy
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.
Change in C-Reactive Protein Level
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.
Time frame: Baseline and Week 4, immediately after completion of the 10th treatment session
Change in Functional Independence Measure Score
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.
Time frame: Baseline and Week 4, immediately after completion of the 10th treatment session
Change in Joint Range of Motion
Joint range of motion of joints affected by burn injury will be assessed using a universal goniometer. Measurements will be recorded in degrees.
Time frame: Baseline and Week 4, immediately after completion of the 10th treatment session
Change in Muscle Strength
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.
Time frame: Baseline and Week 4, immediately after completion of the 10th treatment session
Plan to share: No — Individual participant data will not be shared because the dataset may contain sensitive clinical information related to burn injuries and hospitalization. Data will be used only by the study investigators for the purposes approved by the ethics committee, and confidentiality of participants will be maintained.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Sep 2026, 4 months after the start.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 4 months is below that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
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Fenerbahce University