NCT06542692

Brief Summary

The aim of this study is to examine the effects of whole body vibration therapy on knee osteoarthritis. While the participants did static exercise in one group, whole body vibration therapy was applied during static exercise in another group. As a result of 15 sessions of treatment in both groups, the effects on pain, muscle strength, balance and quality of life were compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

July 19, 2024

Last Update Submit

August 5, 2024

Conditions

Keywords

vibrationwhole body vibrationOsteoarthritisOsteoarthritis, Knee

Outcome Measures

Primary Outcomes (5)

  • visual analog scala

    Scale ranging from 0 to 10 points, where 0 points indicate no pain and 10 points indicate maximum pain.

    3 weeks

  • Womac

    Western Ontario and McMaster Universities Osteoarthritis Index

    3 weeks

  • muscle strength

    isometric muscle strength measurement(knee extension, flexion)

    3 weeks

  • Biodex

    Balance test

    3 weeks

  • Short Form 36

    A test consisting of 36 questions to assess quality of life

    3 weeks

Study Arms (2)

study group

EXPERIMENTAL

Whole body vibration therapy added group

Device: Whole Body VibrationDevice: physical therapy modalities

control group

EXPERIMENTAL
Device: physical therapy modalities

Interventions

treatment duration, frequency

Also known as: physical therapy modalities
study group

ultrasound, hot pack, tens

control groupstudy group

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who were diagnosed with primary symptomatic knee OA according to ACR criteria,Ages between 35 and 70, Body mass index (BMI) ⩽35, Grade II or III according to Kellgren \& Lawrence scale, Patients with persistent symptoms such as pain and stiffness for at least 3 months were included.

You may not qualify if:

  • Those who have had knee surgery before, Those with central nervous system disease (especially epilepsy and serious psychotic disorders), those with a history of acute arthritis, Those with a history of DVT in the last 24 weeks, Those with advanced lung or heart disease (COPD and heart failure), Those diagnosed with inflammatory rheumatic diseases (Rheumatoid arthritis, Spondyloarthropathy, etc.), Patients diagnosed with advanced stage cancer were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 19, 2024

First Posted

August 7, 2024

Study Start

August 28, 2023

Primary Completion

October 20, 2023

Study Completion

December 28, 2023

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations