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.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Cairo、埃及
- Faculty of Physical Therapy, Cairo University
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：TENS Group
Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care
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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.
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安慰剂比较：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
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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International Restless Leg Syndrome Rating Scale (IRLS)
大体时间：Baseline and 4 weeks after treatment
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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).
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Baseline and 4 weeks after treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pressure Pain Threshold
大体时间：Baseline and 4 weeks after treatment
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Assessment of pressure pain threshold using pressure algometry
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Baseline and 4 weeks after treatment
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Plasma Beta-Endorphin Level
大体时间：Baseline and 4 weeks after treatment
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Measurement of plasma beta-endorphin concentration from blood samples
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Baseline and 4 weeks after treatment
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Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline and 4 weeks after treatment
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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).
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Baseline and 4 weeks after treatment
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Short Form-12 Health Survey (SF-12)
大体时间：Baseline and 4 weeks after treatment
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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).
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Baseline and 4 weeks after treatment
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合作者和调查者
调查人员
- 首席研究员：Marwa Mahmoud El Sayed, Assistant Professor、Cairo University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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