Use of transcutaneous electric nerve stimulation for treatment of restless leg syndrome associated with chronic liver disaese

Use of transcutaneous electric nerve stimulation for treatment of restless leg syndrome in chronic liver disease patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053734

Enrollment

Registered

2023-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G258- Other specified extrapyramidal andmovement disorders

Interventions

Intervention1: Transcutaneous Electric Nerve Stimulation: Transcutaneous Electric Nerve Stimulation is traditionally used for pain control in patients with chronic neuropathic pains, mechanical back p

Eligibility

Inclusion criteria

Inclusion criteria: Patients of Chronic Liver Disease defined by progressive deterioration of liver function over 6 months, with age > 18 years, attending Gastromedicine / Neurology OPD at SGPGI and diagnosed with RLS as defined by the International RLS Study Group with Serum Ferritin > 75 ng/ ml at presentation or Non improvement of RLS Symptoms after 6 weeks of Intravenous iron therapy in case with Serum Ferritin < 75 ng/ml.

Exclusion criteria

Exclusion criteria: 1. Active alcohol intake 2. Chronic Kidney diseasedefined by eGFR 3. Recent Hospitalization / recent clinical worsening ( 4. Neurological illnesses like epilepsy disorder/ neuropathy / multiple sclerosis / spinal cord diseases 5. Pregnancy 6. Patients of rls on ongoing treatment with alpha 2 delta ligands / dopaminergic agonists / opioids . 7. Localized skin eruptions 8. Pacemaker

Design outcomes

Primary

Measure	Time frame
To study the efficacy of Transcutaneous Electric Nerve Stimulation in patients of RLS with Chronic Liver Disease in terms of Symptom Severity by International Restless Leg Syndrome Severity ScoreTimepoint: To study the efficacy of Transcutaneous Electric Nerve Stimulation in patients of RLS with Chronic Liver Disease in terms of Symptom Severity by IRLSS Score before therapy and 1 week , 2 week , 4 week and 6 weeks after therapy	—

Measure

Time frame

To study the efficacy of Transcutaneous Electric Nerve Stimulation in patients of RLS with Chronic Liver Disease in terms of Symptom Severity by International Restless Leg Syndrome Severity ScoreTimepoint: To study the efficacy of Transcutaneous Electric Nerve Stimulation in patients of RLS with Chronic Liver Disease in terms of Symptom Severity by IRLSS Score before therapy and 1 week , 2 week , 4 week and 6 weeks after therapy

—

Secondary

Measure	Time frame
To study the Effects on Sleep, Quality of Life and Mood Disorders patients by Pittsburgh Sleep Quality Index ,Hopkins RLS Quality of Life Scores, Hamilton Anxiety and Depression rating scalesTimepoint: Before the start of therapy and 4 weeks after therapy	—

Countries

India

Contacts

Public ContactDr Vimal Kumar Paliwal

Sanjay Gandhi Post Graduate Institute of Medical Sciences

dr_vimalkpaliwal@rediffmail.com9415419759

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026