Status:
COMPLETED
Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Innovative Health Solutions
Conditions:
Irritable Bowel Syndrome
Abdominal Pain
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This is a prospective, double-blind, randomized, sham-controlled pilot study evaluating the efficacy of percutaneous electrical nerve field stimulation for the treatment of adult patients with irritab...
Detailed Description
IBS has a worldwide prevalence around 11% and is characterized by chronic or recurrent abdominal pain associated with altered bowel habits. Abnormalities within the brain-gut axis, visceral hypersensi...
Eligibility Criteria
Inclusion
- Adults, aged 18-60 years, who are able to provide written, informed consent.
- Patients must meet Rome IV criteria for IBS, confirmed by a gastroenterologist who specializes in functional GI disorders. Any of the IBS bowel habit subtypes (diarrhea, constipation, mixed bowel habits, unclassified) will be allowed.
- Average daily worst abdominal pain score between 4 and 8 (on a 0-10-point rating scale).
- Minimum of 2 days of abdominal pain/week prior to starting trial.
- At least moderate IBS symptom severity with an IBS-SSS of at least 175 (total score range 0-500).
- If receiving pharmacologic therapy for abdominal pain associated with IBS, doses must be stable for at least 60 days prior to enrollment in the trial.
- If receiving pharmacologic therapy for IBS that does not have an effect on abdominal pain, doses must be stable for at least 30 days prior to enrollment in the trial.
- Mandatory
Exclusion
- Patients under the age of 18 years or over the age of 60 years
- Patients who cannot provide informed consent or do not speak English
- Co-morbid, organic medical conditions associated with abdominal pain, including: Inflammatory bowel disease, chronic liver disease, peptic ulcer disease, celiac disease, diverticulitis, appendicitis, colorectal cancer, endometriosis, pregnancy, other intestinal or extra-intestinal malignancies. Patients with overlapping functional GI disorders (i.e. functional dyspepsia) will not be excluded as long as IBS is their predominant disorder
- History of surgery involving CN V, VII, IX, or X.
- History of abdominal surgeries other than appendectomy or cholecystectomy at least 6 months before entry into trial.
- Patients on chronic opioids, benzodiazepines, or with illicit substance use
- Patients with underlying neurologic conditions, including history of: seizures, CVA, uncontrolled migraines, traumatic brain injury, multiple sclerosis
- Patients with underlying psychiatric conditions
- Patients with dermatologic conditions affecting the ear, face, or neck region (i.e. psoriasis), or with cuts or abrasions to the external ear that would interfere with needle placement
- Patients with hemophilia or other bleeding disorders
- Patients with any implanted electrical device
- Patients who are pregnant or breastfeeding
- Preferred, but not mandatory, exclusion criteria:
- Movement disorder
- Unwillingness to wear the SmartWatch on upper extremity (left or right wrist)
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04428619
Start Date
August 1 2020
End Date
February 14 2023
Last Update
May 16 2025
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095