Hemodialysis Patients With Restless Legs Syndrome Used Vibration

NCT05249907 | Completed DMC

• 1 other identifier: GTurgay
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

RLS

Keywords

Hemodialysis; Restless leg sendrome; Vibration; Massage

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Control

NO INTERVENTION

No application will be made this group

VIBRATION GROUP

EXPERIMENTAL

Vibration will be applied this group.

Other: Massage

MASSAGE GROUP

EXPERIMENTAL

Massage will be applied this group.

Other: Massage

Interventions

Massage OTHER

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.

Also known as: Vibration

MASSAGE GROUP; VIBRATION GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• psychiatric problems neurological deficit

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, Türkiye, 109861, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Massage; Vibration

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mechanical Phenomena; Physical Phenomena

Study Officials

• Mustafa Gülşen

  Baskent University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: February 22, 2022
• Study Start: February 7, 2023
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 15, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: with in a year
• Access Criteria: pubmed

Locations

TU (1)