Expert review of medical devices · 2025
Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study.
СтатьяКлиническое исследованиеНазвание и аннотация: Перевод в очереди
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Batra Swansu, Paliwal Vimal Kumar, Goel Amit, Gupta Ankit, Kishore Ravi V Krishna, Mishra Ajay Kumar, Garg Sachin, Mishra Prabhakar, Kapoor Vishwas
Аннотация
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 were 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.
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 were 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.