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. 2023 Jun 14:4:1203541.
doi: 10.3389/fpain.2023.1203541. eCollection 2023.

Percutaneous electrical nerve field stimulation improves comorbidities in children with cyclic vomiting syndrome

Katja Karrento  1 , Liyun Zhang  2 , William Conley  1 , Zeeshan Qazi  1 , Thangam Venkatesan  3 , Pippa Simpson  2 , B U K Li  1
Affiliations

Percutaneous electrical nerve field stimulation improves comorbidities in children with cyclic vomiting syndrome

Katja Karrento et al. Front Pain Res (Lausanne). .

Abstract

Introduction: Children with cyclic vomiting syndrome (CVS) frequently suffer from disabling abdominal pain and comorbidities that impair quality of life. A noninvasive, auricular percutaneous electrical nerve field stimulation (PENFS) device is shown to be effective for abdominal pain in children with disorders of gut-brain interaction. We aimed to determine the effects of PENFS on pain, common comorbidities, and quality of life in pediatric CVS.

Methods: Children aged 8-18 years with drug-refractory CVS were enrolled in a prospective, open-label study receiving 6 consecutive weeks of PENFS. Subjects completed the following surveys at baseline, during/after therapy (week 6), and at extended follow-up approximately 4-6 months later: Abdominal Pain Index (API), State-Trait Anxiety Inventory for Children (STAI-C), Pittsburgh Sleep Quality Index (PSQI), and Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-37.

Results: Thirty subjects were included. Median (interquartile range, IQR) age was 10.5 (8.5-15.5) years; 60% were female. Median API scores decreased from baseline to week 6 (p = 0.003) and to extended follow-up (p < 0.0001). State anxiety scores decreased from baseline to week 6 (p < 0.0001) and to extended follow-up (p < 0.0001). There were short-term improvements in sleep at 6 weeks (p = 0.031) but not at extended follow-up (p = 0.22). Quality of life measures of physical function, anxiety, fatigue, and pain interference improved short-term, while there were long-term benefits for anxiety. No serious side effects were reported.

Conclusions: This is the first study to demonstrate the efficacy of auricular neurostimulation using PENFS for pain and several disabling comorbidities in pediatric CVS. PENFS improves anxiety, sleep, and several aspects of quality of life with long-term benefits for anxiety.Clinical trial registration: ClinicalTrials.gov, identifier NCT03434652.

Keywords: abdominal migraine; auricular neurostimulation; cyclic vomiting syndrome (CVS); disorders of gut–brain interaction (DGBI); functional gastrointestinal disorders; percutaneous electrical nerve field stimulation (PENFS); vagus nerve stimulation.

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Conflict of interest statement

TV and BL serve as a consultant for Takeda Pharmaceuticals. KK serves on the Medical Advisory Board for Abbvie and consultant for Neurogastrx. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Weekly pain scores as measured by API during the treatment intervention with significant improvement after 6 weeks of therapy (n = 26 subjects) compared to baseline (p = 0.003). API, abdominal pain index.
Figure 2
Figure 2
STAI-C anxiety state and trait T-scores from baseline to end of therapy and follow-up time point. STAI-C, State-Trait Anxiety Inventory for Children.
Figure 3
Figure 3
Median PSQI scores across study period. PSQI. Pittsburgh Sleep Quality Index.
See this image and copyright information in PMC

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