Hemodialysis, Restless Leg Syndrome (RLS)
Conditions
Brief 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.
Interventions
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.
DEVICEtranscutaneous 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This study is a randomized controlled trial with parallel assignment. Participants will be randomly allocated using a computer-generated randomization sequence (Excel) into two equal groups. Group A will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care. Group B will receive a placebo (sham) TENS intervention with electrodes applied but no electrical stimulation (zero intensity), in addition to standard care.
Eligibility
Sex/Gender
ALL
Age
40 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Restless Leg Syndrome Rating Scale (IRLS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 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). |
| Short Form-12 Health Survey (SF-12) | 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). |
| Pressure Pain Threshold | Baseline and 4 weeks after treatment | Assessment of pressure pain threshold using pressure algometry |
| Plasma Beta-Endorphin Level | Baseline and 4 weeks after treatment | Measurement of plasma beta-endorphin concentration from blood samples |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMarwa Mahmoud El Sayed, Assistant Professor
Cairo University
Outcome results
None listed