Efficacy of Auricular Neurostimulation for Adolescents With Pain-Associated Functional Gastrointestinal Disorders
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Functional Disorder of Intestine
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Pain Frequency-Severity-Duration Scale (PFSD) Score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Katja Kovacic
MD
Medical College of Wisconsin
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- 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))