Effect of Transcutaneous Stellate Ganglion Electrical Stimulation on Restless Leg Syndrome in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- International Restless Leg Syndrome Rating Scale (IRLS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
TENS Group
Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care
干预措施: transcutaneous electrical nerve stimulation (TENS) (Device)
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
干预措施: Sham transcutaneous electrical nerve stimulation (Device)
结局指标
主要结局
International Restless Leg Syndrome Rating Scale (IRLS)
时间窗: 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).
次要结局
- Short Form-12 Health Survey (SF-12)(Baseline and 4 weeks after treatment)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline and 4 weeks after treatment)
研究者
Samar Mohamed Mohamed Mabrouk
Senior physiotherapist at El Kasr El Ainy Hospitals
Cairo University