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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
Kartal
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Istanbul、Kartal、トルコ（Türkiye）、34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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アクティブコンパレータ：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in C-Reactive Protein Level
時間枠：Baseline and Week 4, immediately after completion of the 10th treatment session
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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
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Change in Functional Independence Measure Score
時間枠：Baseline and Week 4, immediately after completion of the 10th treatment session
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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.
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Baseline and Week 4, immediately after completion of the 10th treatment session
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Change in Joint Range of Motion
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Sümeyye Akçay、Fenerbahçe University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- KartalHospital
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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