Neurostimulation through percutaneous electrical nerve field stimulation (PENFS; Neuro-Stim System, Innovative Health Solutions, Versailles, Indiana) was shown to durably reduce pediatric pain in a recent study published in The Lancet Gastroenterology & Hepatology.1
Researchers recruited 115 children age 11 to 18 with chronic abdominal pain related to functional gastrointestinal disorders and randomly assigned them to receive PENFS (n=60) or sham treatment (n=55) for 4 weeks.
The primary efficacy end point of change in abdominal pain scores was measured with the Pain Frequency-Severity-Duration (PFSD) scale.
After 3 weeks of treatment, participants in the PENFS group experienced a greater decrease in worst abdominal pain compared with participants in the sham group (median scores 5.0 vs 7.0; P <.001). Similarly, composite PFSD scores were decreased in the PENFS group compared with the sham group after 3 weeks (mean decrease 11.48; P <.001). At extended follow-up (median 9.2 weeks), the PENFS group continued to report improved worst pain score and PFSD scores (P <.001 and P =.018, respectively).
Adverse events were reported in 10 patients, and included ear discomfort (n=3 in PENFS vs n=3 in sham), adhesive allergy (n=1 in PENFS vs n=2 in sham), and syncope due to needle phobia (n=1 in sham). No serious adverse events were noted.
Adrian Miranda, MD, associate professor in the division of gastroenterology and hepatology, Medical College of Wisconsin, Milwaukee, and lead study investigator, told Clinical Pain Advisor that the research, along with other reports, “suggests that [PENFS] is safe and effective.”
He added that “the implications of this type of non-invasive, neuromodulatory therapy are likely to go beyond [functional abdominal pain disorders],” since future studies could show benefit for “other chronic pain disorders that overlap with [functional abdominal pain disorders] such as fibromyalgia, connective tissue disorders, or even headaches.”
- Kovacic K, Hainsworth K, Sood M, et al. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017;2(10):727-737.