The Effects of Vibration and Instrument Assisted Soft Tissue Manipulation Methods on Pain and Sleep Quality in Hemodialysis Patients With Restless Legs Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sleep quality
研究概览
简要总结
Restless Legs Syndrome (RLS) is a chronic disorder characterized by abnormal sensations, usually accompanied by pain and restlessness in the legs and/or any part of the body. Sleep quality disorders (10-20%) and limb movements during sleep are quite common in patients with RLS . These disorders in sleep quality are also common among patients receiving hemodialysis due to end-stage renal disease.
Pharmacological and non-pharmacological methods are used in the treatment of RLS.
Due to the varying success and side effects of pharmacological treatments, non-pharmacological methods have come to the fore for these patients. One of the methods that can be applied as a non-pharmacological method is vibration.
The therapeutic effect of instrument-assisted soft tissue manipulation (EYYDM) is not clear, it is stated that it activates the muscles, fascia and tendon and improves pain clinically in studies.
The aim of the study is to determine the most effective treatment method on pain and sleep quality by comparing the effects of vibration and EYYDM methods in dialysis patients with restless legs syndrome
详细描述
Restless Legs Syndrome (RLS) is a chronic disorder characterized by abnormal sensations, usually accompanied by pain and restlessness in the legs and/or any part of the body. The typical clinical feature of RLS is the irresistible urge to move and restlessness, especially in the legs, that prevents falling asleep, accompanied by dysesthesia, and the symptoms are more pronounced in the evening and at night, and occur and increase at rest.
Sleep quality disorders (10-20%) and limb movements during sleep are quite common in patients with RLS . These disorders in sleep quality are also common among patients receiving hemodialysis due to end-stage renal disease.
Pharmacological and non-pharmacological methods are used in the treatment of RLS.
Due to the varying success and side effects of pharmacological treatments, non-pharmacological methods have come to the fore for these patients. One of the methods that can be applied as a non-pharmacological method is vibration. Vibration causes an increase in the patient's body temperature, leading, in turn, to increased oxygen release from myoglobin and hemoglobin, increased muscle blood flow, increased sensitivity of neural receptors, increased nerve velocity, and decreased muscle viscosity. It has been stated that all these factors contribute positively to improving health, reducing pain, improving sleep quality, as well as bio-motor and functional indicators.
Although the therapeutic effect of instrument-assisted soft tissue manipulation (EYYDM) is not clear, it is stated that it activates the muscles, fascia and tendon and improves pain clinically in studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Receiving hemodialysis treatment for at least 6 months 3 days a week for 4 hours Patients with RLS according to the diagnostic criteria of the International RLS study group In laboratory examinations the kinetic indicators of dialysis adequacy are within the desired target range (Kt/V: 1.2-1.3; URR: 60-65%) radiological examinations without pathological findings (fracture, dislocation, tumor, infection)
排除标准
- •psychiatric problems neurological deficit
结局指标
主要结局
Sleep quality
时间窗: 1 month later
Sleep quality of the patients will be measured with the pittsburg sleep quality scale.
Massage Group
时间窗: 1 month
Massage will applied for three day a week
Vibration Group
时间窗: 1 month
Vibration will applied for three day a week
次要结局
未报告次要终点
研究者
Gülay Turgay
Assist. Prof.
Baskent University
