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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Cairo, Egipto
- Faculty of Physical Therapy, Cairo University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador de placebos: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
International Restless Leg Syndrome Rating Scale (IRLS)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Baseline and 4 weeks after treatment
|
Assessment of pressure pain threshold using pressure algometry
|
Baseline and 4 weeks after treatment
|
|
Plasma Beta-Endorphin Level
Periodo de tiempo: Baseline and 4 weeks after treatment
|
Measurement of plasma beta-endorphin concentration from blood samples
|
Baseline and 4 weeks after treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marwa Mahmoud El Sayed, Assistant Professor, Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Trastornos del sueño y la vigilia
- Trastornos del Sueño Intrínsecos
- Disomnias
- Parasomnias
- Síndrome de piernas inquietas
- Terapéutica
- Modalidades de fisioterapia
- Rehabilitación
- Anestesia y analgesia
- Terapia de estimulación eléctrica
- Analgesia
- Estimulación del nervio eléctrico transcutáneo
Otros números de identificación del estudio
- SGB-RLS-2026
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .