The Lancet

October 2, 2017

Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial

This randomized, sham controlled trial compared active treatment with PENFS device (Neuraxis) to a sham device that looked the same but without electrical current.  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 115 patients (49% had IBS and 26% had functional dyspepsia).
  2. 0verall, 63-86% of patients in the study had failed to respond to medication therapy.
  3. The median functional disability index (FDI) scores for both the PENFS and sham groups were in the moderate disability range at baseline.

Post-PENFS treatment

  1. Overall, 60% in the active device group had a reduction in worst pain of ≥ 30% compared with 22% in the sham group (p=0.00031).
  2. Patients in the active device group reported feeling better based on the symptom response scale (SRS). 73% in the active device versus 35% in the sham group had SRS scores of 2 or more after 3 weeks of therapy (p=0·00022).
  3. At long-term follow-up, the active device group decreased to the minimal disability range, whereas the sham group remained in the moderate disability range.
  4. There were no significant adverse events.


  1. One of only a few randomized controlled trials in children with chronic abdominal pain and the only device trial.
  2. Results were the first to show the benefit of PENFS compared to sham (placebo) in abdominal pain, global symptoms, and disability. It included children with IBS, functional dyspepsia, abdominal migraine, and functional abdominal pain syndrome.
  3. Pain and disability measures remained improved when evaluated at long-term follow-up (2-3 months) post treatment compared to sham.