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

Primary Purpose

Whole-body Vibration, Arthropathy of Knee, Swelling/ Edema

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Whole body vibration
Sham-Whole body vibration
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whole-body Vibration focused on measuring whole-body vibration, total knee arthroplasty, swelling, edema

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gazi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Whole-body vibration

Sham-whole-body vibration

Arm Description

Standard patient education and exercise training + whole body vibration

Standard patient education and exercise training + sham whole body vibration

Outcomes

Primary Outcome Measures

Baseline pain severity
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Change in pain severity from baseline to day 5 after interventions
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.
Change in the preoperative pain severity on the 7th day of 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.
Change in pain severity from day 7 to day 14 post-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.
Change in pain severity from day 14 to day 21 post-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.
Baseline leg circumference
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Change in leg circumference from baseline to day 5 after interventions
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Change in the preoperative leg circumference on the 7th day of surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Change in leg circumference from day 7 to day 14 post-surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Change in leg circumference from day 14 to day 21 post-surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Baseline range of motion
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Change in range of motion from baseline to day 5 after interventions
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Change in the preoperative range of motion on the 7th day of surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Change in range of motion from day 7 to day 14 post-surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Change in range of motion from day 14 to day 21 post-surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Baseline muscle strength
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Change in muscle strength from baseline to day 5 after interventions
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Change in the preoperative muscle strength on the 7th day of surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Change in muscle strength from day 7 to day 14 post-surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Change in muscle strength from day 14 to day 21 post-surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Baseline skin temperature
A portable infrared thermometer will be used to measure knee skin temperature.
Change in skin temperature from baseline to day 5 after interventions
A portable infrared thermometer will be used to measure knee skin temperature.
Change in the preoperative skin temperature on the 7th day of surgery
A portable infrared thermometer will be used to measure knee skin temperature.
Change in skin temperature from day 7 to day 14 post-surgery
A portable infrared thermometer will be used to measure knee skin temperature.
Change in skin temperature from day 14 to day 21 post-surgery
A portable infrared thermometer will be used to measure knee skin temperature.
Baseline knee proprioception
Active reposition test will be measured using a digital inclinometer device.
Change in knee proprioception from baseline to day 5 after interventions
Active reposition test will be measured using a digital inclinometer device.
Change in the preoperative knee proprioception on the 7th day of surgery
Active reposition test will be measured using a digital inclinometer device.
Change in knee proprioception from day 7 to day 14 post-surgery
Active reposition test will be measured using a digital inclinometer device.
Change in knee proprioception from day 14 to day 21 post-surgery
Active reposition test will be measured using a digital inclinometer device.
Baseline Time Up and Go
functional performance test
Change in Time Up and Go from baseline to day 5 after interventions
functional performance test
Change in the preoperative Time Up and Go on the 7th day of surgery
functional performance test
Change in Time Up and Go from day 7 to day 14 post-surgery
functional performance test
Change in Time Up and Go from day 14 to day 21 post-surgery
functional performance test

Secondary Outcome Measures

SF-36
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.
Change in the preoperative SF-36 on the 21st day of 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.
WOMAC
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.
Change in the preoperative WOMAC on the 21st day of 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.
Global Rating of Change Scales (GROC)
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.

Full Information

First Posted
July 11, 2023
Last Updated
August 24, 2023
Sponsor
Gazi University
Collaborators
Gulhane Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05967637
Brief Title
The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty
Official Title
The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
Collaborators
Gulhane Training and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whole-body Vibration, Arthropathy of Knee, Swelling/ Edema
Keywords
whole-body vibration, total knee arthroplasty, swelling, edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole-body vibration
Arm Type
Experimental
Arm Description
Standard patient education and exercise training + whole body vibration
Arm Title
Sham-whole-body vibration
Arm Type
Sham Comparator
Arm Description
Standard patient education and exercise training + sham whole body vibration
Intervention Type
Other
Intervention Name(s)
Whole body vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham-Whole body vibration
Intervention Description
The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.
Primary Outcome Measure Information:
Title
Baseline pain severity
Description
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Time Frame
baseline
Title
Change in pain severity from baseline to day 5 after interventions
Description
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.
Time Frame
up to 5 days after baseline
Title
Change in the preoperative pain severity on the 7th day of surgery
Description
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Time Frame
up to 7 days after surgery
Title
Change in pain severity from day 7 to day 14 post-surgery
Description
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Time Frame
up to 14 days after surgery
Title
Change in pain severity from day 14 to day 21 post-surgery
Description
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Time Frame
up to 21 days after surgery
Title
Baseline leg circumference
Description
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Time Frame
baseline
Title
Change in leg circumference from baseline to day 5 after interventions
Description
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Time Frame
up to 5 days after baseline
Title
Change in the preoperative leg circumference on the 7th day of surgery
Description
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Time Frame
up to 7 days after surgery
Title
Change in leg circumference from day 7 to day 14 post-surgery
Description
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Time Frame
up to 14 days after surgery
Title
Change in leg circumference from day 14 to day 21 post-surgery
Description
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Time Frame
up to 21 days after surgery
Title
Baseline range of motion
Description
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time Frame
baseline
Title
Change in range of motion from baseline to day 5 after interventions
Description
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time Frame
up to 5 days after baseline
Title
Change in the preoperative range of motion on the 7th day of surgery
Description
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time Frame
up to 7 days after surgery
Title
Change in range of motion from day 7 to day 14 post-surgery
Description
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time Frame
up to 14 days after surgery
Title
Change in range of motion from day 14 to day 21 post-surgery
Description
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time Frame
up to 21 days after surgery
Title
Baseline muscle strength
Description
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time Frame
baseline
Title
Change in muscle strength from baseline to day 5 after interventions
Description
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time Frame
up to 5 days after baseline
Title
Change in the preoperative muscle strength on the 7th day of surgery
Description
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time Frame
up to 7 days after surgery
Title
Change in muscle strength from day 7 to day 14 post-surgery
Description
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time Frame
up to 14 days after surgery
Title
Change in muscle strength from day 14 to day 21 post-surgery
Description
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time Frame
up to 21 days after surgery
Title
Baseline skin temperature
Description
A portable infrared thermometer will be used to measure knee skin temperature.
Time Frame
baseline
Title
Change in skin temperature from baseline to day 5 after interventions
Description
A portable infrared thermometer will be used to measure knee skin temperature.
Time Frame
up to 5 days after baseline
Title
Change in the preoperative skin temperature on the 7th day of surgery
Description
A portable infrared thermometer will be used to measure knee skin temperature.
Time Frame
up to 7 days after surgery
Title
Change in skin temperature from day 7 to day 14 post-surgery
Description
A portable infrared thermometer will be used to measure knee skin temperature.
Time Frame
up to 14 days after surgery
Title
Change in skin temperature from day 14 to day 21 post-surgery
Description
A portable infrared thermometer will be used to measure knee skin temperature.
Time Frame
up to 21 days after surgery
Title
Baseline knee proprioception
Description
Active reposition test will be measured using a digital inclinometer device.
Time Frame
baseline
Title
Change in knee proprioception from baseline to day 5 after interventions
Description
Active reposition test will be measured using a digital inclinometer device.
Time Frame
up to 5 days after baseline
Title
Change in the preoperative knee proprioception on the 7th day of surgery
Description
Active reposition test will be measured using a digital inclinometer device.
Time Frame
up to 7 days after surgery
Title
Change in knee proprioception from day 7 to day 14 post-surgery
Description
Active reposition test will be measured using a digital inclinometer device.
Time Frame
up to 14 days after surgery
Title
Change in knee proprioception from day 14 to day 21 post-surgery
Description
Active reposition test will be measured using a digital inclinometer device.
Time Frame
up to 21 days after surgery
Title
Baseline Time Up and Go
Description
functional performance test
Time Frame
baseline
Title
Change in Time Up and Go from baseline to day 5 after interventions
Description
functional performance test
Time Frame
up to 5 days after baseline
Title
Change in the preoperative Time Up and Go on the 7th day of surgery
Description
functional performance test
Time Frame
up to 7 days after surgery
Title
Change in Time Up and Go from day 7 to day 14 post-surgery
Description
functional performance test
Time Frame
up to 14 days after surgery
Title
Change in Time Up and Go from day 14 to day 21 post-surgery
Description
functional performance test
Time Frame
up to 21 days after surgery
Secondary Outcome Measure Information:
Title
SF-36
Description
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.
Time Frame
baseline
Title
Change in the preoperative SF-36 on the 21st day of surgery
Description
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.
Time Frame
up to 21 days after surgery
Title
WOMAC
Description
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.
Time Frame
before interventions, 21st day after surgery
Title
Change in the preoperative WOMAC on the 21st day of surgery
Description
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.
Time Frame
up to 21 days after surgery
Title
Global Rating of Change Scales (GROC)
Description
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.
Time Frame
up to 21st day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sevim Beyza Olmez
Phone
+90 312 216 26 21
Email
sevimbeyzaolmez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Hazar
Organizational Affiliation
Gazi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cemil Yıldız
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sevim Beyza Ölmez
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beyza Yazgan
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İnci Ayaş
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Department of Physiotherapy and Rehabilitation, Prof
Phone
+90 312 2162601
Email
sbfogrenciisleri@gazi.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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