Stellate Ganglion Stimulation for Restless Leg Syndrome in Hemodialysis Patients
Key facts
- Who runs it
- Cairo University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 36 people enrolled
- Started
- 10 Oct 2025
- Ended
- 30 May 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- transcutaneous electrical nerve stimulation (TENS)
- Sham transcutaneous electrical nerve stimulation
- Record updated
- 22 June 2026
Who can take part
- Age
- 40 years to 50 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 36 patients will be involved in this study according to the following criteria; Patient undergoes four main clinical criteria for the diagnosis of RLS according to the international restless leg syndrome study group (IRLSSG) including; 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; Male and Female patients; The age will range from 40-50 years old; BMI (Body Mass Index 25-34.9 kg/m2; Patients with grade 2 Hypertension (160-179/100-109 mmHg); Hemodialysis patients for at least 1year and have restless leg syndrome (RLS)
Who cannot take part
- History of Deep venous thrombosis; History of Bleeding disorders; Have an implantable device like a pacemaker; Recent Infected wound; History of allergic response to the electrodes, gel or tape; patients who participating in any other exercise program; Loss of sensation or numbness
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- TENS GroupTreatment being tested
Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care
Treatment: transcutaneous electrical nerve stimulation (TENS)
- Sham Stimulation Control GroupPlacebo, for comparison
Patients will receive a placebo (sham) TENS intervention with electrodes applied but no electrical stimulation (zero intensity), in addition to standard care
Treatment: Sham transcutaneous electrical nerve stimulation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Transcutaneous Stellate Ganglion Electrical Stimulation on Restless Leg Syndrome in Hemodialysis Patients
- Record updated
- 22 June 2026