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Hemodialysis Patients With Restless Legs Syndrome Used Vibration

Primary Purpose

RLS

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for RLS focused on measuring Hemodialysis, Restless leg sendrome, Vibration, Massage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

VIBRATION GROUP

MASSAGE GROUP

Arm Description

No application will be made this group

Vibration will be applied this group.

Massage will be applied this group.

Outcomes

Primary Outcome Measures

Massage Group
Massage will applied for three day a week
Vibration Group
Vibration will applied for three day a week
Sleep quality
Sleep quality of the patients will be measured with the pittsburg sleep quality scale.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2021
Last Updated
February 7, 2023
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT05249907
Brief Title
Hemodialysis Patients With Restless Legs Syndrome Used Vibration
Official Title
The Effects of Vibration and Instrument Assisted Soft Tissue Manipulation Methods on Pain and Sleep Quality in Hemodialysis Patients With Restless Legs Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RLS
Keywords
Hemodialysis, Restless leg sendrome, Vibration, Massage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No application will be made this group
Arm Title
VIBRATION GROUP
Arm Type
Experimental
Arm Description
Vibration will be applied this group.
Arm Title
MASSAGE GROUP
Arm Type
Experimental
Arm Description
Massage will be applied this group.
Intervention Type
Other
Intervention Name(s)
Massage
Other Intervention Name(s)
Vibration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Massage Group
Description
Massage will applied for three day a week
Time Frame
1 month
Title
Vibration Group
Description
Vibration will applied for three day a week
Time Frame
1 month
Title
Sleep quality
Description
Sleep quality of the patients will be measured with the pittsburg sleep quality scale.
Time Frame
1 month later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Gülşen
Organizational Affiliation
Baskent University
Official's Role
Study Director
Facility Information:
Facility Name
Baskent University
City
Ankara
State/Province
Türkiye
ZIP/Postal Code
109861
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Article
IPD Sharing Time Frame
with in a year
IPD Sharing Access Criteria
pubmed

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Hemodialysis Patients With Restless Legs Syndrome Used Vibration

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