A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders

A Pilot Study of a Randomized Sham-control Auricular TENS Unit Stimulation to Improve Symptoms Through Vagal Modulation in Pediatric Functional Gastrointestinal Disorders

The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. The study will compare two methods of stimulation to determine if there is a difference in the two methods.

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 report pain on a 0-10 visual analog scale.