Efficacy of Auricular Neurostimulation for Adolescents With Pain-Associated Functional Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Pain Frequency-Severity-Duration Scale (PFSD) Score
研究概览
简要总结
This study evaluates the effectiveness of a neurostimulator applied to the outer ear for adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve stimulation to a branch of the vagus nerve which is thought to be involved in transmission of pain signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one.
详细描述
The vagus nerve innervates the gastrointestinal tract and influences the autonomic nervous system. It is thought to carry signals of discomfort and nausea to the brain where it is interpreted. The autonomic nervous system may be in imbalance in patients with functional gastrointestinal disorders. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in adolescents with functional abdominal pain with or without nausea.
Subjects will be randomized into two groups: 1) neurostimulation versus 2) sham. They will receive either an active or non-active (sham group) device for 5 days each week x 4 weeks total. Pain, nausea, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored weekly for the entire study as well as after the study is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents with a major complaint of abdominal pain (minimum 3/10 in severity) with or without nausea (minimum 3/10 in severity) of unclear etiology, who are English-speaking and willing to participate and consent to the study and who have a parent willing to participate.
- •Patients with symptoms of minimum three times per week for a duration of two months or greater
- •Intact external ear that is free of infection or severe dermatological conditions.
- •Stable vital signs for their respective age
排除标准
- •Medically complex children or those who take a medication or suffer from an organic disease that can explain symptoms will be excluded from participation.
- •Children or parents, who have developmental delay, will be excluded due to difficulties in accurately completing the questionnaires and assessing symptoms.
- •History of seizures
- •Currently implanted electrical device
- •Orthostatic hypotension
研究组 & 干预措施
Neurostimulator
Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks
干预措施: Neurostimulator (Device)
Sham Neurostimulator
Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks
干预措施: Sham (Device)
结局指标
主要结局
Pain Frequency-Severity-Duration Scale (PFSD) Score
时间窗: Change from Baseline to Week 4
One-page, 6-item pain measure assessing pain symptoms over the past week. Measures the typical and worst pain intensity, frequency and duration over the past week in units on a scale from 0 to 10 (10 being the worst pain imaginable). Worst pain = primary outcome.
次要结局
- Nausea Profile(Change from Baseline to week 4 in Nausea Profile score.)
- Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (PGH-7)(Change from Baseline (Pre) to 2-3 months after end of therapy (Post))
- Functional Disability Inventory (FDI)(Change from Baseline (Pre) to 2-3 months after end of therapy (Post))
- State-Trait Anxiety Inventory for Children (STAI-C)(Change from Baseline (Pre) to 2-3 months after end of therapy (Post))
研究者
Katja Kovacic
MD
Medical College of Wisconsin