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Percutaneous electrical nerve field stimulation improves comorbidities in children with cyclic vomiting syndrome
Katja Karrento1, Liyun Zhang2, William Conley1
1Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, United States.
Insights
Percutaneous electrical nerve field stimulation (PENFS) effectively reduced abdominal pain and anxiety in children with cyclic vomiting syndrome (CVS). This noninvasive auricular treatment also improved sleep and quality of life, with lasting anxiety benefits.
Area of Science:
- Pediatric Gastroenterology
- Neuroscience
- Medical Devices
Background:
- Cyclic Vomiting Syndrome (CVS) in children causes severe abdominal pain and comorbidities, significantly impacting their quality of life.
- Disorders of gut-brain interaction are common in pediatric CVS.
- Auricular percutaneous electrical nerve field stimulation (PENFS) is a noninvasive option for abdominal pain in these conditions.
Purpose of the Study:
- To evaluate the efficacy of PENFS in managing abdominal pain in pediatric CVS patients.
- To assess the impact of PENFS on common comorbidities associated with CVS.
- To determine the effects of PENFS on the overall quality of life in children with CVS.
Main Methods:
- A prospective, open-label study involving 30 children (aged 8-18) with drug-refractory CVS.
- 6 weeks of consecutive auricular PENFS treatment.
- Assessment using validated questionnaires for pain (API), anxiety (STAI-C), sleep (PSQI), and quality of life (PROMIS Pediatric Profile-37) at baseline, 6 weeks, and 4-6 months follow-up.
Main Results:
- Significant reductions in Abdominal Pain Index (API) scores were observed at 6 weeks and extended follow-up (p<0.003).
- State anxiety scores significantly decreased at both 6 weeks and extended follow-up (p<0.0001).
- Short-term improvements in sleep and quality of life (physical function, anxiety, fatigue, pain interference) were noted, with long-term anxiety benefits.
Conclusions:
- This study is the first to show PENFS efficacy for pain and comorbidities in pediatric CVS.
- Auricular PENFS offers a promising noninvasive treatment option for pediatric CVS.
- PENFS demonstrates significant benefits for anxiety, sleep, and quality of life, with sustained effects on anxiety.
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.
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