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Stellate Ganglion Stimulation for Restless Leg Syndrome in Hemodialysis Patients

NCT07657013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-22

No results posted yet for this study

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.

Conditions

  • Restless Leg Syndrome (RLS)
  • Hemodialysis

Interventions

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.

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Marwa Mahmoud El Sayed, Assistant Professor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2026-03-10
Completion
2026-05-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07657013 on ClinicalTrials.gov