Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Jul;22(7):757-765.
doi: 10.1080/17434440.2025.2508872. Epub 2025 May 20.

Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study

Swansu Batra  1 , Vimal Kumar Paliwal  1 , Amit Goel  2 , Ankit Gupta  1 , Ravi V Krishna Kishore  3 , Ajay Kumar Mishra  2 , Sachin Garg  1 , Prabhakar Mishra  4 , Vishwas Kapoor  4
Affiliations
Clinical Trial

Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study

Swansu Batra et al. Expert Rev Med Devices. 2025 Jul.

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 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.

Keywords: Restless leg syndrome; chronic liver disease; cirrhosis; sleep-related movement disorder; transcutaneous electric nerve stimulation.

Plain language summary

Restless leg syndrome (RLS) is a sleep-related movement disorder characterized by an unpleasant or uncomfortable urge to move legs during periods of rest. RLS is highly prevalent among patients with cirrhosis of the liver. Moderate-to-severe RLS interferes with sleep, produces daytime sleepiness, and results in anxiety and depressive symptoms. The International Restless Legs Syndrome Study Group recommends pharmaceutical therapies; however, these can risk liver toxicity and altered levels of consciousness. Therefore, we studied transcutaneous electric nerve stimulation (TENS) in restless leg syndrome to evaluate its efficacy by reducing RLS severity and its role in improving sleep quality, anxiety, and depressive symptoms. We provided TENS by applying electric current generated by portable battery-operated device through a pair of electrodes placed on each leg. Each TENS treatment session was 30 minutes daily for consecutive 7 days. RLS symptom severity was assessed by the IRLSS (Restless Leg Syndrome rating scale) at baseline before the TENS and at 7 days, 2 weeks, 4 weeks, and 6 weeks after TENS treatment. Hindi translation of well-standardized scales was used to quantify sleep quality, quality of life, depression, and anxiety before the TENS (baseline) and after 4 weeks of TENS. Twenty-five patients (mean age 52 ± 9.1 years, 52% females) received TENS. Mean Restless Leg Syndrome rating scale score improved from 22.28 ± 6.724 (baseline) to 6.08 ± 5.590, 7.48 ± 7.206, 8.56 ± 6.715, and 11.76 ± 5.456 after 1, 2, 4, and 6 weeks. TENS produced maximum improvement in Restless Leg Syndrome ratings after 1 week, with continued improvement up to 6 weeks. Sleep quality, quality of life, anxiety, and depression scores improved after 4 weeks of TENS and the improvement was independent to baseline Restless Leg Syndrome rating scale score.

PubMed Disclaimer

Similar articles

See all similar articles

Publication types

LinkOut - more resources