Skip to main content
OpenTrials
Completed

NCT Number: NCT02367729

Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Disorder of Intestine Nausea Persistent

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neurostimulator

Device

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

SHAM

Device

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

Primary outcomes

  1. Pain Frequency-Severity-Duration Scale (PFSD) Score

    Time frame: 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.

Secondary outcomes

  1. Nausea Profile

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

    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.

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

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

    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.

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

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

    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.

  4. Functional Disability Inventory (FDI)

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

    15-item instrument, each question rated on a five-point scale (0="no trouble" to 4="impossible"), indicating how much difficulty subjects have doing common childhood activities because of their physical health. A total score is summed (range 0-60) with higher score indicating worse outcome (greater pain-related disability). Scored were compared before (Pre) and after (Post) treatment intervention.

Other outcomes

  1. Questionnaire on Pediatric Gastrointestinal Symptoms, Rome III (QPGS-RIII), Reporting the Number of Participants With Specific Diagnoses

    Time frame: Baseline only (diagnostic criteria)

    Nine-page, validated, parent-report questionnaire that assesses symptoms associated with pediatric functional GI disorders to diagnose the following specific Rome III criteria: Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, Functional Abdominal Pain and Functional Abdominal Pain Syndrome. The number of participants with these specific diagnoses at baseline were reported, including overlapping diagnoses.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • American Neurogastroenterology and Motility Society

Registry information

Official study title

Efficacy of Auricular Neurostimulation for Adolescents With Pain-Associated Functional Gastrointestinal Disorders

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 20, 2015
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.