Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

Nausea Persistent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367729
• Other study ID #: KovacicK
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2018
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Functional Disorder of Intestine
• Gastrointestinal Diseases
• Intestinal Diseases
• Nausea Persistent

Intervention

Device:
• Neurostimulator
Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks.
• Sham
Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks.

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	American Neurogastroenterology and Motility Society

Country where clinical trial is conducted

United States, 

References & Publications (6)

Asher GN, Jonas DE, Coeytaux RR, Reilly AC, Loh YL, Motsinger-Reif AA, Winham SJ. Auriculotherapy for pain management: a systematic review and meta-analysis of randomized controlled trials. J Altern Complement Med. 2010 Oct;16(10):1097-108. doi: 10.1089/a — View Citation

Busch V, Zeman F, Heckel A, Menne F, Ellrich J, Eichhammer P. The effect of transcutaneous vagus nerve stimulation on pain perception--an experimental study. Brain Stimul. 2013 Mar;6(2):202-9. doi: 10.1016/j.brs.2012.04.006. Epub 2012 May 7. — View Citation

Kraus T, Kiess O, Hösl 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.20 — View 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. 20 — View 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 — View Citation

Sator-Katzenschlager SM, Wölfler MM, Kozek-Langenecker SA, Sator K, Sator PG, Li B, Heinze G, Sator MO. Auricular electro-acupuncture as an additional perioperative analgesic method during oocyte aspiration in IVF treatment. Hum Reprod. 2006 Aug;21(8):211 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire on Pediatric Gastrointestinal Symptoms, Rome III (QPGS-RIII), Reporting the Number of Participants With Specific Diagnoses	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.	Baseline only (diagnostic criteria)
Primary	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.	Change from Baseline to Week 4
Secondary	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.	Change from Baseline to week 4 in Nausea Profile score.
Secondary	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.	Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
Secondary	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.	Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
Secondary	Functional Disability Inventory (FDI)	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.	Change from Baseline (Pre) to 2-3 months after end of therapy (Post)