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

NCT05967637 | Completed

• 1 other identifier: 2023-874
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

whole-body vibration; total knee arthroplasty; swelling; edema

Outcome Measures

Primary Outcomes (35)

• 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.

  baseline

• 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.

  up to 5 days after baseline

• 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.

  up to 7 days after surgery

• 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.

  up to 14 days after surgery

• 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.

  up to 21 days after surgery

• 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.

  baseline

• 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.

  up to 5 days after baseline

• 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.

  up to 7 days after surgery

• 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.

  up to 14 days after surgery

• 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.

  up to 21 days after surgery

• Baseline range of motion

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  A portable infrared thermometer will be used to measure knee skin temperature.

  baseline

• Change in skin temperature from baseline to day 5 after interventions

  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

  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

  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

  A portable infrared thermometer will be used to measure knee skin temperature.

  up to 21 days after surgery

• Baseline knee proprioception

  Active reposition test will be measured using a digital inclinometer device.

  baseline

• Change in knee proprioception from baseline to day 5 after interventions

  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

  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

  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

  Active reposition test will be measured using a digital inclinometer device.

  up to 21 days after surgery

• Baseline Time Up and Go

  functional performance test

  baseline

• Change in Time Up and Go from baseline to day 5 after interventions

  functional performance test

  up to 5 days after baseline

• Change in the preoperative Time Up and Go on the 7th day of surgery

  functional performance test

  up to 7 days after surgery

• Change in Time Up and Go from day 7 to day 14 post-surgery

  functional performance test

  up to 14 days after surgery

• Change in Time Up and Go from day 14 to day 21 post-surgery

  functional performance test

  up to 21 days after surgery

Secondary Outcomes (5)

• SF-36

  baseline

• Change in the preoperative SF-36 on the 21st day of surgery

  up to 21 days after surgery

• WOMAC

  before interventions, 21st day after surgery

• Change in the preoperative WOMAC on the 21st day of surgery

  up to 21 days after surgery

• Global Rating of Change Scales (GROC)

  up to 21st day after surgery

Study Arms (2)

Whole-body vibration

EXPERIMENTAL

Standard patient education and exercise training + whole body vibration

Other: Whole body vibration

Sham-whole-body vibration

SHAM COMPARATOR

Standard patient education and exercise training + sham whole body vibration

Other: Sham-Whole body vibration

Interventions

Whole body vibration OTHER

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.

Whole-body vibration

Sham-Whole body vibration OTHER

The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.

Sham-whole-body vibration

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead
• Gulhane Training and Research Hospital: collaborator

Study Sites (1)

Gazi University

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeynep Hazar

  Gazi University

  STUDY DIRECTOR

• Cemil Yıldız

  Gulhane Training and Research Hospital

  STUDY CHAIR

• Sevim Beyza Ölmez

  Gazi University

  PRINCIPAL INVESTIGATOR

• Beyza Yazgan

  Gazi University

  PRINCIPAL INVESTIGATOR

• İnci Ayaş

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 1, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)