CompletedNot Applicable

Stellate Ganglion Stimulation for Restless Leg Syndrome in Hemodialysis Patients

Egypt36 participantsStarted 2025-10-10

Plain-language summary

This randomized controlled trial investigated the effect of transcutaneous stellate ganglion electrical nerve stimulation (TENS-SG) on restless legs syndrome (RLS) in patients undergoing hemodialysis. Thirty-six patients aged 40-50 years were randomly assigned to two equal groups: Group A received active TENS-SG applied over the cervical-thoracic (stellate ganglion) region three times weekly for four weeks, while Group B received placebo stimulation. The study evaluated multiple outcomes including RLS severity (IRLS scale), sleep quality (PSQI), quality of life (SF-12), pain perception (pressure pain threshold), blood pressure, psychological status (HADS), and plasma β-endorphin levels. Results demonstrated that TENS-SG significantly reduced RLS severity and improved sleep quality, pain threshold, quality of life, and psychological well-being compared to placebo. It also significantly reduced systolic and diastolic blood pressure and markedly increased β-endorphin levels. Overall, the findings suggest that TENS-SG is a safe, non-invasive, and effective intervention for improving neurological, cardiovascular, psychological, and quality-of-life outcomes in hemodialysis patients with RLS.

Who can participate

Age range

40 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. an urge to move legs that is usually associated with paresthesia.
. alleviation of the symptoms by moving the legs.
. aggravation or exacerbation of the symptoms particularly at rest or during sitting or lying down in the bed.
. worsening of the signs at night.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at stellate ganglion stimulation for restless leg syndrome specifically in hemodialysis patients — since I'm on dialysis and have RLS, does my situation closely match the patients who were studied, and would those results be relevant to me?
2The trial used the International Restless Leg Syndrome Rating Scale to measure outcomes — do you know how much improvement in those scores was actually seen, and would that level of improvement be meaningful for my day-to-day symptoms?
3Stellate ganglion stimulation targets a nerve cluster in the neck — what are the main risks or side effects associated with stimulating that area, and how do they compare to the medications or other treatments I'm already using or could try?
4Since this trial is completed and not an ongoing experimental study, does that mean stellate ganglion stimulation for RLS in dialysis patients is something any specialist could offer me now, or is it still considered investigational?
5Before considering a procedure like stellate ganglion stimulation, are there standard treatments for dialysis-related restless leg syndrome — like medication adjustments or changes to my dialysis schedule — that we should try first?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

International Restless Leg Syndrome Rating Scale (IRLS)

Timeframe: Baseline and 4 weeks after treatment

Trial details

NCT IDNCT07657013

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-10

View on ClinicalTrials.gov More Restless Leg Syndrome (RLS) trials