N/A
N=15
Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome
Irritable Bowel Syndrome · Abdominal Pain · Autonomic Nervous System Imbalance
Bottom Line
View on ClinicalTrials.gov: NCT04428619 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Mean Change in IBS Symptom Severity From Baseline — 280; 320; 244; 316 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peripheral Electrical Nerve Field Stimulation (PENFS) Device (Device); Sham Device (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in IBS Symptom Severity From Baseline |
280; 320; 244; 316 | — |
| SECONDARY Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 4 Weeks. |
2.83; 0.574; 2.21; 0.592 | — |
| SECONDARY IBS Symptom Severity Responder Rate |
3; 2 | — |
| SECONDARY Mean Change in Average Daily Worst Abdominal Pain From Baseline |
5.02; 5.03 | — |
| SECONDARY Change in Average Daily Stool Consistency From Baseline |
2.91; 3.78 | — |
| SECONDARY Change in Average Weekly Bowel Habits From Baseline |
51.5; 62.8; 53.8; 61.3 | — |
| SECONDARY Change in Quality of Life From Baseline |
66.8; 42.1; 42.3; 74.7 | — |
| SECONDARY "Number of Participants With Treatment-related Adverse Events as Assessed by a Weekly Adverse Events Questionnaire |
0; 0 | — |
| SECONDARY Change in Average Weekly Bloating Symptoms From Baseline |
58.2; 65.0; 56.7; 64.2 | — |
| SECONDARY Change in Average Weekly Abdominal Pain Symptoms From Baseline |
65.8; 69.4; 62.8; 69.3 | — |
| SECONDARY Chang in Average Weekly Bowel Habits From Baseline |
59.9; 63.4; 50.8; 54.8 | — |
| SECONDARY Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at Baseline. |
1.26; 6.66; 1.70; 5.13 | — |
| SECONDARY Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at Baseline. |
1.26; 6.66; 1.70; 5.13 | — |
| SECONDARY Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 4 Weeks. |
2.83; 0.574; 2.21; 0.592 | — |
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).
Eligibility Criteria
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 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)
Data sourced from ClinicalTrials.gov (NCT04428619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.