Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

Medical College of Wisconsin115 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

115

Conditions

Functional Disorder of Intestine Nausea Persistent

Interventions

NeurostimulatorDEVICE

Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks.

ShamDEVICE

Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Pain Frequency-Severity-Duration Scale (PFSD) Score

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.

Time frame: Change from Baseline to Week 4

Secondary Outcomes

Nausea Profile

Two page, 17-item questionnaire which measures the subjective experience of nausea on a scale from 0 (not at all) to 9 (severely) across three dimensions: 1) somatic distress; 2) gastrointestinal distress and 3) emotional distress. Total score 153.

Time frame: Change from Baseline to week 4 in Nausea Profile score.

State-Trait Anxiety Inventory for Children (STAI-C)

State-Trait Anxiety Inventory for Children (STAI-C). State anxiety measured by 20-item questionnaire assessing anxiety at a particular moment in time on a 3-point rating scale. Raw scores (range 20-60) were converted to normalized T-Scores based on a population of healthy school children (mean=50; standard deviation=10) with higher score indicating worse outcome. Effects of intervention on state anxiety was assessed before (pre) and after (post) therapy.

Time frame: Change from Baseline (Pre) to 2-3 months after end of therapy (Post)

Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (PGH-7)

A 7-item instrument that measures quality of life in relation to health. Each question has five response options (scored 1-5 units on a scale). A total raw sum score is generated, ranging from lowest score of 7 and highest score of 35 with higher scores indicating better outcome (improved quality of life). The raw score is converted to a standardized T-score (mean=50; standard deviation=10) based on a population of healthy children. T-scores were compared before (Pre) and after (Post) treatment intervention.

Time frame: Change from Baseline (Pre) to 2-3 months after end of therapy (Post)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.