This randomized, sham controlled trial compared active treatment with PENFS device (Neuraxis) to a sham device. Included only adolescents with irritable bowel syndrome (IBS). Validated questionnaires for pain, global symptoms and functional disability were administered to both groups at baseline, weekly intervals and 2-3 months post treatment.

Baseline findings

1. The cohort include 50 patients with IBS (27 received active treatment vs. 23 sham).
2. 70-91% of patients in the study had failed to respond to medication therapy.

Post-PENFS treatment

1. Overall, 59% of patients receiving active PENFS therapy compared with 26% of patients receiving sham showed ≥30% reduction in worst abdominal pain from baseline.
2. The number needed to treat (NNT) to get the targeted 30% improvement in worst pain severity was 3.
3. 81% of IBS patients in the active PENFS group compared with 26% of the sham (P < .001) reported overall symptom improvement, respectively using a higher cutoff score of ≥
4. There were no significant adverse events.

Significance

1. The first and only randomized controlled trial with a PENFS device in adolescents with IBS.
2. Results were the first to show the benefit of PENFS compared to sham device in adolescents with IBS.
3. Pain and global symptom measures remained improved when evaluated at long-term follow-up (2-3 months) post treatment compared to sham.