Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome (NCT04428619) | Clinical Trial Compass
CompletedNot Applicable
Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome
United States15 participantsStarted 2020-08-01
Plain-language 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 irritable bowel syndrome (IBS).
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…