Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

NCT02367729 | Completed Results

• 1 other identifier: KovacicK
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Disorder of Intestine; Nausea Persistent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Nausea Profile

  Change from Baseline to week 4 in Nausea Profile score.

• State-Trait Anxiety Inventory for Children (STAI-C)

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

• 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)

Other Outcomes (1)

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

  Baseline only (diagnostic criteria)

Study Arms (2)

Neurostimulator

EXPERIMENTAL

Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks

Device: Neurostimulator

Sham Neurostimulator

SHAM COMPARATOR

Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks

Device: Sham

Interventions

Neurostimulator DEVICE

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

Neurostimulator

Sham DEVICE

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

Sham Neurostimulator

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• American Neurogastroenterology and Motility Society: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (8)

• Sator-Katzenschlager SM, Wolfler 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):2114-20. doi: 10.1093/humrep/del110. Epub 2006 May 5.

  PMID: 16679325 RESULT

• 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.

  PMID: 14570667 RESULT

• 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/acm.2009.0451.

  PMID: 20954963 RESULT

• 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.

  PMID: 22621941 RESULT

• 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.

  PMID: 23453934 RESULT

• 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.

  PMID: 15105215 RESULT

• 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.

  PMID: 31622740 DERIVED

• 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.

  PMID: 28826627 DERIVED

MeSH Terms

Interventions

Implantable Neurostimulators

Intervention Hierarchy (Ancestors)

Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants

Results Point of Contact

• Title: Dr. Katja Kovacic
• Organization: Medical College of Wisconsin

kkovacic@mcw.edu

4142663915

Study Officials

• Katja Kovacic, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 1, 2015
• First Posted: February 20, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: November 8, 2018
• Results First Posted: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)