Stellate Ganglion Stimulation for Restless Leg Syndrome in Hemodialysis Patients

Effect of Transcutaneous Stellate Ganglion Electrical Stimulation on Restless Leg Syndrome in Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Restless Leg Syndrome (RLS)
• Intervention / Treatment: Device: transcutaneous electrical nerve stimulation (TENS); Device: Sham transcutaneous electrical nerve stimulation

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Physical Therapy, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

    1. an urge to move legs that is usually associated with paresthesia.
    2. alleviation of the symptoms by moving the legs.
    3. aggravation or exacerbation of the symptoms particularly at rest or during sitting or lying down in the bed.
    4. 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS Group; Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care	Device: transcutaneous electrical nerve stimulation (TENS); Transcutaneous electrical nerve stimulation is applied over the stellate ganglion region three times per week for four weeks. The stimulation is used as a non-invasive neuromodulation technique to manage restless legs syndrome in hemodialysis patients.
Placebo Comparator: Sham Stimulation Control Group; Patients will receive a placebo (sham) TENS intervention with electrodes applied but no electrical stimulation (zero intensity), in addition to standard care	Device: Sham transcutaneous electrical nerve stimulation; Electrodes are applied over the same anatomical site as the active intervention; however, no electrical current is delivered (zero intensity). The procedure mimics the active treatment to ensure blinding of participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Restless Leg Syndrome Rating Scale (IRLS)	Assessment of restless legs syndrome severity using the International Restless Legs Syndrome Rating Scale	Baseline and 4 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI	Assessment of sleep quality using the Pittsburgh Sleep Quality Index	Baseline and 4 weeks after treatment
Short Form-12 Health Survey (SF-12)	Assessment of health-related quality of life using the SF-12 questionnaire	Baseline and 4 weeks after treatment
Pressure Pain Threshold	Assessment of pressure pain threshold using pressure algometry	Baseline and 4 weeks after treatment
Plasma Beta-Endorphin Level	Measurement of plasma beta-endorphin concentration from blood samples	Baseline and 4 weeks after treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Marwa Mahmoud El Sayed, Assistant Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2025
• Primary Completion (Actual): March 10, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Restless Legs Syndrome; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: SGB-RLS-2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No