Trial Outcomes & Findings for Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome (NCT NCT04428619)

Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome

To compare the efficacy of PENFS therapy versus sham therapy on the change in IBS symptom severity in adult IBS patients after 4 weeks of treatment and at extended follow-up (8 weeks), assessed through a mean change in the IBS-SSS between groups. Answers were measured using the IBS-SSS. Higher scores indicate worse symptoms. The score range is 0-500.

Same measures as outcome measure 12. LF peak FFT: Peak frequency within the low-frequency range (typically 0.04-0.15 Hz) of the HRV spectrum HF peak FFT: Peak frequency within the high-frequency range (typically 0.15-0.4 Hz) of the HRV spectrum. VLF peak AR: Peak frequency within the very-low-frequency range (typically 0.0033-0.04 Hz) of the HRV spectrum. HF peak AR: Peak frequency within the high-frequency range of the HRV spectrum. LF peak AR: Peak frequency within the low-frequency range of the HRV spectrum.

To compare the efficacy of PENFS therapy versus sham therapy on the change in IBS symptom severity in adult IBS patients after 4 weeks of treatment compared to baseline. Participants will be considered responders if there is at least a 50-point reduction on the IBS-SSS.

To compare the efficacy of PENFS therapy versus sham therapy on mean worst daily abdominal pain scores after 4 weeks compared to baseline in adult patients with IBS. The scale is measured as follows, with higher scores indicating worse pain: Daily Worse Abdominal Pain Severity: • How would you rate your worst abdominal pain over the past 24-hours (0-10)? o 0 = no pain, 10= worst pain possible

To compare the efficacy of PENFS therapy versus sham therapy on the change in average daily stool consistency after 4 weeks of treatment compared to baseline, assessed using the Bristol Stool Form Scale (BSFS) (stool types 1-7; types 1 and 2 indicate constipation, types 3 and 4 are normal consistency stools, type 5 indicates stool lacking fiber, types 6 and 7 indicate diarrhea).

To compare the efficacy of PENFS therapy versus sham therapy on the change in average weekly bowel habits after 4 weeks of treatment and at extended follow-up (8 weeks) compared to baseline, assessed through the PROMIS Gastrointestinal Constipation Scale (percentiles 0.3-100%; higher percentiles indicate greater constipation).

To compare the efficacy of PENFS therapy versus sham therapy on the change in IBS-quality of life (IBS-QOL) in adult patients with IBS after 4 weeks of treatment and at extended follow-up (8 weeks) compared to baseline. IBS QOL will be assessed on a scale from 0-100, with higher scores indicating better IBS specific quality of life.

To compare the incidence of treatment-related adverse events from PENFS therapy versus sham therapy in adult patients with IBS. Adverse events will be assessed by a weekly adverse events questionnaire that determines the severity of the adverse event, the relationship to the study intervention, the action taken regarding the study intervention, the outcome of the adverse event, whether or not the adverse event was expected, and if the event was considered a serious adverse event (SAE).

To compare the efficacy of PENFS therapy versus sham therapy on the change in average weekly bloating symptoms at 4 weeks and at extended follow-up (8 weeks) compared to baseline, assessed through the PROMIS Gastrointestinal Gas and Bloating Scale (percentiles 0.1-100%; higher percentiles indicate greater gas and bloating).

To compare the efficacy of PENFS therapy versus sham therapy on the change in average weekly abdominal pain symptoms at 4 weeks and at extended follow-up (8 weeks) compared to baseline, assessed through the PROMIS Gastrointestinal Belly Pain Scale (percentiles 2-100%; higher percentiles indicate worse abdominal pain).

To compare the efficacy of PENFS therapy versus sham therapy on the change in average weekly bowel habits after 4 weeks of treatment and at extended follow-up (8 weeks) compared to baseline, assessed through the PROMIS Gastrointestinal Diarrhea Scale (percentiles 1-100%; higher percentiles indicate greater diarrhea).

LF peak FFT: Peak frequency within the low-frequency range (typically 0.04-0.15 Hz) of the HRV spectrum, as determined by Fast Fourier Transform (FFT) analysis. HF peak FFT: Represents the peak frequency within the high-frequency range (typically 0.15-0.4 Hz) of the HRV spectrum, as determined by FFT analysis. VLF peak AR: Represents the peak frequency within the very-low-frequency range (typically 0.0033-0.04 Hz) of the HRV spectrum, as determined by autoregressive (AR) modeling. HF peak AR: Represents the peak frequency within the high-frequency range of the HRV spectrum, as determined by AR modeling. LF peak AR: Represents the peak frequency within the low-frequency range of the HRV spectrum, as det

HF/LF ratio FFT: Ratio of high-frequency to low-frequency ratio in heart rate variability (HRV) analysis, as determined by FFT analysis. It reflects the balance between parasympathetic (HF) and sympathetic (LF) nervous system activity influencing heart rate. HF/LF ratio ACT: Ratio of high-frequency to low-frequency ratio in heart rate variability (HRV) analysis, as determined by AR modeling. It reflects the balance between parasympathetic (HF) and sympathetic (LF) nervous system activity influencing heart rate.

HF/LF ratio AR: Ratio of high-frequency to low-frequency ratio in heart rate variability (HRV) analysis, as determined by AR. It reflects the balance between parasympathetic (HF) and sympathetic (LF) nervous system activity influencing heart rate. HF/LF ratio FFT: Ratio of high-frequency to low-frequency ratio in heart rate variability (HRV) analysis; reflects the balance between parasympathetic (HF) and sympathetic (LF) nervous system activity influencing heart rate.