Hemodialysis Patients With Restless Legs Syndrome Used Vibration

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

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

Study Overview

• Status: Completed
• Conditions: RLS
• Intervention / Treatment: Other: Massage

Detailed Description

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.

In Turkey, no study investigating the effects of vibration and EYYDM in hemodialysis patients diagnosed with RLS has been found. In this direction, 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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Türkiye
    • Ankara, Türkiye, Turkey, 109861
      • Baskent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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)

Exclusion Criteria:

psychiatric problems neurological deficit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No application will be made this group
Experimental: VIBRATION GROUP; Vibration will be applied this group.	Other: Massage; Stroking ("stroking") movement will be performed on the soft tissue parallel to the muscle fibers on the origo and insertion lines. Vaseline will be preferred as an intermediate to increase the lubricity of the instrument. The frequency of patting and friction movements will be 60 repetitions per minute. Starting from the medial side of the gastrocnemius (calf) muscle in both legs and moving it longitudinally from distal to proximal and from back to distal in a straight line within 20 seconds, for 2.5 minutes. Then this treatment will be applied to the lateral side of the gastrocnemius muscle for 2.5 minutes.; Other Names: Vibration
Experimental: MASSAGE GROUP; Massage will be applied this group.	Other: Massage; Stroking ("stroking") movement will be performed on the soft tissue parallel to the muscle fibers on the origo and insertion lines. Vaseline will be preferred as an intermediate to increase the lubricity of the instrument. The frequency of patting and friction movements will be 60 repetitions per minute. Starting from the medial side of the gastrocnemius (calf) muscle in both legs and moving it longitudinally from distal to proximal and from back to distal in a straight line within 20 seconds, for 2.5 minutes. Then this treatment will be applied to the lateral side of the gastrocnemius muscle for 2.5 minutes.; Other Names: Vibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Massage Group	Massage will applied for three day a week	1 month
Vibration Group	Vibration will applied for three day a week	1 month
Sleep quality	Sleep quality of the patients will be measured with the pittsburg sleep quality scale.	1 month later

Collaborators and Investigators

• Sponsor: Baskent University
• Investigators: Study Director: Mustafa Gülşen, Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Vibration; Massage; Hemodialysis; Restless leg sendrome
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Parasomnias; Psychomotor Agitation; Restless Legs Syndrome
• Other Study ID Numbers: GTurgay

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Article
• IPD Sharing Time Frame: with in a year
• IPD Sharing Access Criteria: pubmed
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No