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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Cairo, Egypte
- Faculty of Physical Therapy, Cairo University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La 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
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: TENS Group
Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care
|
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.
|
|
Comparateur placebo: 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
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
International Restless Leg Syndrome Rating Scale (IRLS)
Délai: 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).
|
Baseline and 4 weeks after treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pressure Pain Threshold
Délai: Baseline and 4 weeks after treatment
|
Assessment of pressure pain threshold using pressure algometry
|
Baseline and 4 weeks after treatment
|
|
Plasma Beta-Endorphin Level
Délai: Baseline and 4 weeks after treatment
|
Measurement of plasma beta-endorphin concentration from blood samples
|
Baseline and 4 weeks after treatment
|
|
Pittsburgh Sleep Quality Index (PSQI)
Délai: 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).
|
Baseline and 4 weeks after treatment
|
|
Short Form-12 Health Survey (SF-12)
Délai: 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).
|
Baseline and 4 weeks after treatment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marwa Mahmoud El Sayed, Assistant Professor, Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Les troubles mentaux
- Troubles du sommeil et de l'éveil
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Parasomnies
- Syndrome des jambes sans repos
- Thérapeutique
- Modalités de physiothérapie
- Réhabilitation
- Anesthésie et analgésie
- Thérapie de stimulation électrique
- Analgésie
- Stimulation du nerf électrique transcutané
Autres numéros d'identification d'étude
- SGB-RLS-2026
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .