Swansu Batra, Vimal Kumar Paliwal, Amit Goel, Ankit Gupta, Ravi V Krishna Kishore, Ajay Kumar Mishra, Sachin Garg, Prabhakar Mishra, Vishwas Kapoor
{"title":"Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study.","authors":"Swansu Batra, Vimal Kumar Paliwal, Amit Goel, Ankit Gupta, Ravi V Krishna Kishore, Ajay Kumar Mishra, Sachin Garg, Prabhakar Mishra, Vishwas Kapoor","doi":"10.1080/17434440.2025.2508872","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The study aimed to evaluate the effect of transcutaneous electric nerve stimulation (TENS) on restless leg syndrome (RLS) severity, sleep, quality of life, anxiety, and depression in liver cirrhosis patients.</p><p><strong>Research design and methods: </strong>This was single-arm, open label, pilot study. Cirrhosis patients with RLS were evaluated with International RLS Score (IRLSS, scored 0-40 for severity) at baseline and 1, 2, 4, 6 weeks. Sleep quality, quality of life, depression and anxiety was assessed using Pittsburg Sleep Quality Index (PSQI, 0-21 with poor sleep), RLS Quality of Life Questionnaire (RLSQoL, 18 items, 13 scored 0-15, higher score - good quality of life), Hamilton Depression Rating Scale (HAM-D, scored 0-53 with increasing depression) and Hamilton Anxiety Rating Scale (HAM-A, scored 0 to 56 with increasing anxiety) at baseline and 4 weeks of TENS.</p><p><strong>Results: </strong>Twenty-five patients (mean age 52 ± 9.1 years, 52% females) received TENS. Mean IRLSS improved from 22.28 ± 6.724 to 6.08 ± 5.590, 7.48 ± 7.206, 8.56 ± 6.715, 11.76 ± 5.456 after 1, 2, 4 and 6 weeks. Baseline Sleep quality, quality of life, anxiety and depression scores (9.6 ± 5.1, 73 ± 20.7, 25.4 ± 11.7, 19.2 ± 10.6) improved after 4 weeks of TENS (4.7 ± 3, 94.9 ± 12.5, 8.9 ± 5.7,7.5 ± 5).</p><p><strong>Conclusion: </strong>Transcutaneous Electric Nerve Stimulation improved RLS symptoms, sleep quality, anxiety, depression, and overall quality of life in cirrhosis patients.</p><p><strong>Trial registration: </strong>Clinical Trial Registry of India - CTRI/2023/06/053734.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert review of medical devices","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/17434440.2025.2508872","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background: The study aimed to evaluate the effect of transcutaneous electric nerve stimulation (TENS) on restless leg syndrome (RLS) severity, sleep, quality of life, anxiety, and depression in liver cirrhosis patients.
Research design and methods: This was single-arm, open label, pilot study. Cirrhosis patients with RLS were evaluated with International RLS Score (IRLSS, scored 0-40 for severity) at baseline and 1, 2, 4, 6 weeks. Sleep quality, quality of life, depression and anxiety was assessed using Pittsburg Sleep Quality Index (PSQI, 0-21 with poor sleep), RLS Quality of Life Questionnaire (RLSQoL, 18 items, 13 scored 0-15, higher score - good quality of life), Hamilton Depression Rating Scale (HAM-D, scored 0-53 with increasing depression) and Hamilton Anxiety Rating Scale (HAM-A, scored 0 to 56 with increasing anxiety) at baseline and 4 weeks of TENS.
Results: Twenty-five patients (mean age 52 ± 9.1 years, 52% females) received TENS. Mean IRLSS improved from 22.28 ± 6.724 to 6.08 ± 5.590, 7.48 ± 7.206, 8.56 ± 6.715, 11.76 ± 5.456 after 1, 2, 4 and 6 weeks. Baseline Sleep quality, quality of life, anxiety and depression scores (9.6 ± 5.1, 73 ± 20.7, 25.4 ± 11.7, 19.2 ± 10.6) improved after 4 weeks of TENS (4.7 ± 3, 94.9 ± 12.5, 8.9 ± 5.7,7.5 ± 5).
Conclusion: Transcutaneous Electric Nerve Stimulation improved RLS symptoms, sleep quality, anxiety, depression, and overall quality of life in cirrhosis patients.
Trial registration: Clinical Trial Registry of India - CTRI/2023/06/053734.