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Stellate Ganglion Stimulation for Restless Leg Syndrome in Hemodialysis Patients

15. juni 2026 opdateret af: Samar Mohamed Mohamed Mabrouk, Cairo University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TENS Group
Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care
Enhed: 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 komparator: 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
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
International Restless Leg Syndrome Rating Scale (IRLS)
Tidsramme: Baseline and 4 weeks after treatment
Assessment of restless legs syndrome severity using the International Restless Legs Syndrome Rating Scale
Baseline and 4 weeks after treatment

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Efterforskere

  • Ledende efterforsker: Marwa Mahmoud El Sayed, Assistant Professor, Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. oktober 2025

Primær færdiggørelse (Faktiske)

10. marts 2026

Studieafslutning (Faktiske)

30. maj 2026

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SGB-RLS-2026

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med transcutaneous electrical nerve stimulation (TENS)

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