The Effect of Whole Body Vibration on Muscle Elasticity | NCT06521983

Studies
The Effect of Whole Body Vibration on Muscle Elasticity

NCT06521983

Sponsor

Gaziantep Islam Science and Technology University

Status

Completed

Last Update Posted

Jul 30, 2024Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Lordosis; Postural
Lordosis
Hyperlordosis

Interventions

Whole body vibration

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2023Actual

Primary Completion Date

Apr 20, 2024Actual

Completion Date

Jun 28, 2024Actual

First Submitted Date

Jul 10, 2024

First Submission Date that Met QC Criteria

Jul 23, 2024

First Posted Date

Jul 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2024

Last Update Posted Date

Jul 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gönül Elpeze, Assistant Proffessor, Gaziantep Islam Science and Technology UniversityPrincipal Investigator

Lead Sponsor

Gaziantep Islam Science and Technology UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study examined the effect of whole-body vibration on pain and muscle elasticity in individuals with hyperlordosis and normal lordosis.

Flexible ruler for individuals' spinal curvatures (lumbar lordosis); back-lower back pain levels VAS; muscle elasticity Myoton Pro device; Physical functions will be evaluated with the Modified Oswestry low back pain scale.

Detailed Description

This study examined the effect of whole-body vibration on pain and muscle elasticity in individuals with hyperlordosis and normal lordosis.

The viscoelasticity properties ( tone, stiffness, elasticity) of the Musculus Trapezius and Musculus Pectoralis were assessed with MyotonPro® (Myoton AS, Estonia) during prone position on both sides.

Individuals will be divided into two groups: hyperlordosis and normal lordosis. Whole body vibration will be applied twice a week for six weeks, with a frequency of 30 Hz and an intensity of 2 mm.

A total of 28 females and males (14 individuals for each group) with hyperlordosis (>40°) and normal lordosis participated in the study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LORDOSİS	Experimental	30-40	Other: Whole body vibration
HYPERLORDOSİS	Experimental	40<	Other: Whole body vibration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whole body vibration	Other	Whole body vibration will be applied while standing with a frequency of 30 Hz and an intensity of 2 mm by vibration machine	HYPERLORDOSİS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle viscoelastic properties	muscle stiffness	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pain level	Visual Analog Scale: between 0 -10 points; 0 (zero) no pain; 5 (five) Moderate pain; 10 (ten) Worst possible Pain	6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being over 18 years of age,
Having pain >5 according to VAS measurement,
Having normal lumbar lordosis angle between 30°-40°,
Having hyperlordosis angle >40°

Exclusion Criteria:

Having Scheurmann kyphosis, ,
Having scoliosis (Cobb angle >10°),
Having other congenital spine abnormalities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gonul Elpeze	Gaziantep Islam Science and Technology University Physical Therapy and Rehabilitation Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziantep Islam Science and Technology University		Gaziantep			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008141	Lordosis
D013540	Swayback

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

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Browse Branches

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