search
Back to results

Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

Primary Purpose

Functional Disorder of Intestine, Nausea Persistent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurostimulator
Sham
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Disorder of Intestine

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Neurostimulator

Sham Neurostimulator

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 1, 2015
Last Updated
October 11, 2018
Sponsor
Medical College of Wisconsin
Collaborators
American Neurogastroenterology and Motility Society
search

1. Study Identification

Unique Protocol Identification Number
NCT02367729
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
American Neurogastroenterology and Motility Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Disorder of Intestine, Nausea Persistent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurostimulator
Arm Type
Experimental
Arm Description
Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks
Arm Title
Sham Neurostimulator
Arm Type
Sham Comparator
Arm Description
Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks
Intervention Type
Device
Intervention Name(s)
Neurostimulator
Intervention Description
Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks.
Primary Outcome Measure Information:
Title
Pain Frequency-Severity-Duration Scale (PFSD) Score
Description
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.
Time Frame
Change from Baseline to Week 4
Secondary Outcome Measure Information:
Title
Nausea Profile
Description
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.
Time Frame
Change from Baseline to week 4 in Nausea Profile score.
Title
State-Trait Anxiety Inventory for Children (STAI-C)
Description
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.
Time Frame
Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
Title
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (PGH-7)
Description
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.
Time Frame
Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
Title
Functional Disability Inventory (FDI)
Description
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.
Time Frame
Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
Other Pre-specified Outcome Measures:
Title
Questionnaire on Pediatric Gastrointestinal Symptoms, Rome III (QPGS-RIII), Reporting the Number of Participants With Specific Diagnoses
Description
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.
Time Frame
Baseline only (diagnostic criteria)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Kovacic, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16679325
Citation
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.
Results Reference
result
PubMed Identifier
14570667
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.
Results Reference
result
PubMed Identifier
20954963
Citation
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.
Results Reference
result
PubMed Identifier
22621941
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.
Results Reference
result
PubMed Identifier
23453934
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.
Results Reference
result
PubMed Identifier
15105215
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.
Results Reference
result
PubMed Identifier
31622740
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.
Results Reference
derived
PubMed Identifier
28826627
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.
Results Reference
derived

Learn more about this trial

Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

We'll reach out to this number within 24 hrs