The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty

July 8, 2025 updated by: Sevim Beyza Ölmez, Gazi University
The study's objective is to investigate the effects of whole-body vibration therapy administered before surgery on various factors related to patients who undergo total knee arthroplasty. These factors include pain, swelling, skin temperature, normal joint movement, knee joint position sense, knee extensor muscle strength, functional status, and patient satisfaction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will include participants aged 50-80 who are planning to undergo total knee arthroplasty. According to the sample size analysis, a total of 40 people will be included in this study. The enrolled participants will be randomly assigned to one of two parallel groups: the whole-body vibration group or the sham whole-body vibration group. Both groups will receive standard patient education and exercise training.The experimental group will receive whole-body vibration along with exercise on the whole-body vibration device, while the control group (sham group) will receive sham vibration on the same device. All participants will receive treatment for a total of 5 days, one session per day.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey, 06490
        • Gazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with advanced idiopathic knee OA and scheduled for unilateral total knee arthroplasty will be considered candidates for the present study and will be asked to participate

Exclusion Criteria:

  • if they had undergone another hip or knee joint replacement in the previous year
  • if they had any medical condition in which exercise was contraindicated
  • if they had any disease that affected functional performance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Whole-body vibration
Standard patient education and exercise training + whole body vibration
Other: Whole body vibration
The vibration will be applied for 10 minutes (30 seconds rest, 30 seconds training, 10 reps) in total with a low frequency (20 HZ) and low amplitude (2mm). Participants will be asked to stand in a squatting position by semi-flexing (30°) their knees during the 30-second vibration period.
Sham Comparator: Sham-whole-body vibration
Standard patient education and exercise training + sham whole body vibration
Other: Sham-Whole body vibration
The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline pain severity
Time Frame: baseline
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
baseline
Change in pain severity from baseline to day 5 after interventions
Time Frame: up to 5 days after baseline
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.pain and 10 representing maximal pain.
up to 5 days after baseline
Change in the preoperative pain severity on the 7th day of surgery
Time Frame: up to 7 days after surgery
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
up to 7 days after surgery
Change in pain severity from day 7 to day 14 post-surgery
Time Frame: up to 14 days after surgery
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
up to 14 days after surgery
Change in pain severity from day 14 to day 21 post-surgery
Time Frame: up to 21 days after surgery
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
up to 21 days after surgery
Baseline leg circumference
Time Frame: baseline
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
baseline
Change in leg circumference from baseline to day 5 after interventions
Time Frame: up to 5 days after baseline
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
up to 5 days after baseline
Change in the preoperative leg circumference on the 7th day of surgery
Time Frame: up to 7 days after surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
up to 7 days after surgery
Change in leg circumference from day 7 to day 14 post-surgery
Time Frame: up to 14 days after surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
up to 14 days after surgery
Change in leg circumference from day 14 to day 21 post-surgery
Time Frame: up to 21 days after surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
up to 21 days after surgery
Baseline range of motion
Time Frame: baseline
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
baseline
Change in range of motion from baseline to day 5 after interventions
Time Frame: up to 5 days after baseline
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
up to 5 days after baseline
Change in the preoperative range of motion on the 7th day of surgery
Time Frame: up to 7 days after surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
up to 7 days after surgery
Change in range of motion from day 7 to day 14 post-surgery
Time Frame: up to 14 days after surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
up to 14 days after surgery
Change in range of motion from day 14 to day 21 post-surgery
Time Frame: up to 21 days after surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
up to 21 days after surgery
Baseline muscle strength
Time Frame: baseline
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
baseline
Change in muscle strength from baseline to day 5 after interventions
Time Frame: up to 5 days after baseline
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
up to 5 days after baseline
Change in the preoperative muscle strength on the 7th day of surgery
Time Frame: up to 7 days after surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
up to 7 days after surgery
Change in muscle strength from day 7 to day 14 post-surgery
Time Frame: up to 14 days after surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
up to 14 days after surgery
Change in muscle strength from day 14 to day 21 post-surgery
Time Frame: up to 21 days after surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
up to 21 days after surgery
Baseline skin temperature
Time Frame: baseline
A portable infrared thermometer will be used to measure knee skin temperature.
baseline
Change in skin temperature from baseline to day 5 after interventions
Time Frame: up to 5 days after baseline
A portable infrared thermometer will be used to measure knee skin temperature.
up to 5 days after baseline
Change in the preoperative skin temperature on the 7th day of surgery
Time Frame: up to 7 days after surgery
A portable infrared thermometer will be used to measure knee skin temperature.
up to 7 days after surgery
Change in skin temperature from day 7 to day 14 post-surgery
Time Frame: up to 14 days after surgery
A portable infrared thermometer will be used to measure knee skin temperature.
up to 14 days after surgery
Change in skin temperature from day 14 to day 21 post-surgery
Time Frame: up to 21 days after surgery
A portable infrared thermometer will be used to measure knee skin temperature.
up to 21 days after surgery
Baseline knee proprioception
Time Frame: baseline
Active reposition test will be measured using a digital inclinometer device.
baseline
Change in knee proprioception from baseline to day 5 after interventions
Time Frame: up to 5 days after baseline
Active reposition test will be measured using a digital inclinometer device.
up to 5 days after baseline
Change in the preoperative knee proprioception on the 7th day of surgery
Time Frame: up to 7 days after surgery
Active reposition test will be measured using a digital inclinometer device.
up to 7 days after surgery
Change in knee proprioception from day 7 to day 14 post-surgery
Time Frame: up to 14 days after surgery
Active reposition test will be measured using a digital inclinometer device.
up to 14 days after surgery
Change in knee proprioception from day 14 to day 21 post-surgery
Time Frame: up to 21 days after surgery
Active reposition test will be measured using a digital inclinometer device.
up to 21 days after surgery
Baseline Time Up and Go
Time Frame: baseline
functional performance test
baseline
Change in Time Up and Go from baseline to day 5 after interventions
Time Frame: up to 5 days after baseline
functional performance test
up to 5 days after baseline
Change in the preoperative Time Up and Go on the 7th day of surgery
Time Frame: up to 7 days after surgery
functional performance test
up to 7 days after surgery
Change in Time Up and Go from day 7 to day 14 post-surgery
Time Frame: up to 14 days after surgery
functional performance test
up to 14 days after surgery
Change in Time Up and Go from day 14 to day 21 post-surgery
Time Frame: up to 21 days after surgery
functional performance test
up to 21 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SF-36
Time Frame: baseline
The 36-Item Short-Form Health Survey (SF-36) is a general scoring instrument used to provide a health profile comprised of eight scaled scores. Each scale is instantly turned into a 0-100 scale, allowing identification of the patient's physical and mental status. A higher score means a better result.
baseline
Change in the preoperative SF-36 on the 21st day of surgery
Time Frame: up to 21 days after surgery
The 36-Item Short-Form Health Survey (SF-36) is a general scoring instrument used to provide a health profile comprised of eight scaled scores. Each scale is instantly turned into a 0-100 scale, allowing identification of the patient's physical and mental status. A higher score means a better result.
up to 21 days after surgery
WOMAC
Time Frame: before interventions, 21st day after surgery
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-report multidimensional questionnaire that assesses pain, stiffness, and physical functional disability. A higher score means a better result.
before interventions, 21st day after surgery
Change in the preoperative WOMAC on the 21st day of surgery
Time Frame: up to 21 days after surgery
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-report multidimensional questionnaire that assesses pain, stiffness, and physical functional disability. A higher score means a better result.
up to 21 days after surgery
Global Rating of Change Scales (GROC)
Time Frame: up to 21st day after surgery
The GROC score, which has seven response options ranging from 'much worse' (a score of 0) to 'much better' (a score of six), will be used to determine the subject's perception of overall improvement.
up to 21st day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gulhane Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sevim Beyza Ölmez, Gazi University
  • Study Director: Zeynep Hazar, Gazi University
  • Study Chair: Cemil Yıldız, Gulhane Training and Research Hospital
  • Principal Investigator: Beyza Yazgan, Gazi University
  • Principal Investigator: İnci Ayaş, Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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