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临床试验/NCT05249907
NCT05249907已完成不适用

The Effects of Vibration and Instrument Assisted Soft Tissue Manipulation Methods on Pain and Sleep Quality in Hemodialysis Patients With Restless Legs Syndrome

Baskent University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月7日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülay Turgay

Assist. Prof.

Baskent University

研究点 (2)

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