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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS Group | Experimental | Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care |
|
| Sham Stimulation Control Group | Placebo Comparator | Patients will receive a placebo (sham) TENS intervention with electrodes applied but no electrical stimulation (zero intensity), in addition to standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| International Restless Leg Syndrome Rating Scale (IRLS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 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) |
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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
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
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| Name | Affiliation | Role |
|---|---|---|
| Marwa Mahmoud El Sayed, Assistant Professor | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy, Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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.
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|
| 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. |
|
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 |
| Pressure Pain Threshold | Assessment of pressure pain threshold using pressure algometry | Baseline and 4 weeks after treatment |
| Plasma Beta-Endorphin Level | Measurement of plasma beta-endorphin concentration from blood samples | Baseline and 4 weeks after treatment |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |