Clinical trial NCT02367729: Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain
Official title: Efficacy of Auricular Neurostimulation for Adolescents With Pain-Associated Functional Gastrointestinal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Disorder of Intestine
Nausea Persistent
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: American Neurogastroenterology and Motility Society
First posted: 2015-02-20
Enrollment: 115
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Frequency-Severity-Duration Scale (PFSD) Score
timeFrame: Change from Baseline to Week 4
Secondary outcomes:
measure: Nausea Profile
timeFrame: Change from Baseline to week 4 in Nausea Profile score.
measure: State-Trait Anxiety Inventory for Children (STAI-C)
timeFrame: Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (PGH-7)
timeFrame: Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
measure: Functional Disability Inventory (FDI)
timeFrame: Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
Other outcomes:
measure: Questionnaire on Pediatric Gastrointestinal Symptoms, Rome III (QPGS-RIII), Reporting the Number of Participants With Specific Diagnoses
timeFrame: Baseline only (diagnostic criteria)
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Katja Kovacic, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sator-Katzenschlager SM, Szeles JC, Scharbert G, Michalek-Sauberer A, Kober A, Heinze G, Kozek-Langenecker SA. Electrical stimulation of auricular acupuncture points is more effective than conventional manual auricular acupuncture in chronic cervical pain: a pilot study. Anesth Analg. 2003 Nov;97(5):1469-1473. doi: 10.1213/01.ANE.0000082246.67897.0B.
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citation: Kraus T, Kiess O, Hosl K, Terekhin P, Kornhuber J, Forster C. CNS BOLD fMRI effects of sham-controlled transcutaneous electrical nerve stimulation in the left outer auditory canal - a pilot study. Brain Stimul. 2013 Sep;6(5):798-804. doi: 10.1016/j.brs.2013.01.011. Epub 2013 Feb 13.
citation: Sator-Katzenschlager SM, Scharbert G, Kozek-Langenecker SA, Szeles JC, Finster G, Schiesser AW, Heinze G, Kress HG. The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. Anesth Analg. 2004 May;98(5):1359-64, table of contents. doi: 10.1213/01.ane.0000107941.16173.f7.
citation: Krasaelap A, Sood MR, Li BUK, Unteutsch R, Yan K, Nugent M, Simpson P, Kovacic K. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1987-1994.e2. doi: 10.1016/j.cgh.2019.10.012. Epub 2019 Oct 14.
citation: Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.