N/A
Completed N=115
Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain
Functional Disorder of Intestine · Nausea Persistent
Source: ClinicalTrials.gov NCT02367729 ↗
Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pain Frequency-Severity-Duration Scale (PFSD) Score — 5.0; 7.0 units on a scale — p=0.003
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Frequency-Severity-Duration Scale (PFSD) Score |
5.0; 7.0 | 0.003 sig |
| SECONDARY Nausea Profile |
25.5; 20.0 | — |
| SECONDARY State-Trait Anxiety Inventory for Children (STAI-C) |
54.0; 54.0; 52.0; 54.0 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (PGH-7) |
42.1; 37.2; 42.1; 38.8 | — |
| SECONDARY Functional Disability Inventory (FDI) |
17.0; 17.0; 11; 17.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02367729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.