A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
Functional Gastrointestinal Disorders, Vagus Nerve Autonomic Disorder, Irritable Bowel Syndrome
About this trial
This is an interventional treatment trial for Functional Gastrointestinal Disorders
Eligibility Criteria
Inclusion Criteria:
- Female patients 12-18 years old with chronic idiopathic nausea, function abdominal pain, dyspepsia and/or irritable bowel syndrome
- English Speaking
Exclusion Criteria:
- Patients who are unable to stand upright during the heart rate variability recording
- Patients with a known bleeding disorder
- Gastric or cardiac pacer or defibrillator
- Poor circulation in lower limbs
- Swollen or inflamed outer ear
- Epilepsy
- Abdominal or inguinal hernia
- Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.
- Requires new medication during the 8 weeks of the study that may affect gastrointestinal symptoms, vagal modulation or immune response
- Inability to answer questionnaires or repoty pain in a 0-10 visual analog scale.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active Stimulation (8)
Sham Stimulation (4), Active (4)
Participants will receive active auricular microstimulation via TENS unit for 8 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).