Karrento Katja, Zhang Liyun, Conley William, Qazi Zeeshan, Venkatesan Thangam, Simpson Pippa, Li B U K
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, United States.
Division of Quantitative Health Sciences, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, United States.
Front Pain Res (Lausanne). 2023 Jun 14;4:1203541. doi: 10.3389/fpain.2023.1203541. eCollection 2023.
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.
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.
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 ( = 0.003) and to extended follow-up ( < 0.0001). State anxiety scores decreased from baseline to week 6 ( < 0.0001) and to extended follow-up ( < 0.0001). There were short-term improvements in sleep at 6 weeks ( = 0.031) but not at extended follow-up ( = 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.
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.: ClinicalTrials.gov, identifier NCT03434652.
周期性呕吐综合征（CVS）患儿经常遭受致残性腹痛及共病困扰，这些会损害生活质量。一种非侵入性的耳穴经皮电神经场刺激（PENFS）设备已被证明对患有肠-脑相互作用障碍的儿童腹痛有效。我们旨在确定PENFS对小儿CVS疼痛、常见共病及生活质量的影响。
年龄在8至18岁、药物难治性CVS患儿纳入一项前瞻性、开放标签研究，接受连续6周的PENFS治疗。受试者在基线、治疗期间/治疗后（第6周）以及大约4至6个月后的延长随访时完成以下调查：腹痛指数（API）、儿童状态-特质焦虑量表（STAI-C）、匹兹堡睡眠质量指数（PSQI）以及患者报告结局测量信息系统（PROMIS）儿童概况-37。
纳入30名受试者。中位（四分位间距，IQR）年龄为10.5（8.5 - 15.5）岁；60%为女性。从基线到第6周（P = 0.003）以及到延长随访时（P < 0.0001），API中位评分降低。状态焦虑评分从基线到第6周（P < 0.0001）以及到延长随访时（P < 0.0001）降低。在6周时睡眠有短期改善（P = 0.031），但在延长随访时没有（P = 0.22）。身体功能、焦虑、疲劳和疼痛干扰方面的生活质量指标短期有所改善，而焦虑有长期益处。未报告严重副作用。
这是第一项证明使用PENFS进行耳穴神经刺激对小儿CVS疼痛及几种致残性共病有效的研究。PENFS可改善焦虑、睡眠及生活质量的多个方面，对焦虑有长期益处。：ClinicalTrials.gov，标识符NCT03434652。
