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NCT Number: NCT07657013

Stellate Ganglion Stimulation for 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.

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Key information

Conditions

Restless Leg Syndrome (RLS) Dyssomnias Hemodialysis Mental Disorders Nervous System Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

40 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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).

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

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation (TENS)

Device

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.

Sham Transcutaneous Electrical Nerve Stimulation

Device

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.

Primary outcomes

  1. International Restless Leg Syndrome Rating Scale (IRLS)

    Time frame: Baseline and 4 weeks after treatment

    Assessment of restless legs syndrome severity using the International Restless Legs Syndrome Rating Scale. The scale consists of 10 items with a total score ranging from 0 to 40, where higher scores indicates greater symptoms severity (worse outcome).

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and 4 weeks after treatment

    Assessment of sleep quality using the Pittsburgh Sleep Quality Index. the total score ranges from 0 to 21, where higher scores indicate poorer sleep quality (worse outcome).

  2. Short Form-12 Health Survey (SF-12)

    Time frame: Baseline and 4 weeks after treatment

    Assessment of health-related quality of life using the SF-12 questionnaire. physical and mental component summary scores typically range from 0 to 100, where higher scores indicate better health related quality of life (better outcome).

  3. Pressure Pain Threshold

    Time frame: Baseline and 4 weeks after treatment

    Assessment of pressure pain threshold using pressure algometry

  4. Plasma Beta-Endorphin Level

    Time frame: Baseline and 4 weeks after treatment

    Measurement of plasma beta-endorphin concentration from blood samples

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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