Clinical trial NCT05967637: 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
Overall status: RECRUITING
Phase: NA
Conditions: Whole-body Vibration
Arthropathy of Knee
Swelling/ Edema
Keywords: whole-body vibration
total knee arthroplasty
swelling
edema
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Gulhane Training and Research Hospital
First posted: 2023-08-01
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Baseline pain severity
timeFrame: baseline
measure: Change in pain severity from baseline to day 5 after interventions
timeFrame: up to 5 days after baseline
measure: Change in the preoperative pain severity on the 7th day of surgery
timeFrame: up to 7 days after surgery
measure: Change in pain severity from day 7 to day 14 post-surgery
timeFrame: up to 14 days after surgery
measure: Change in pain severity from day 14 to day 21 post-surgery
timeFrame: up to 21 days after surgery
measure: Baseline leg circumference
timeFrame: baseline
measure: Change in leg circumference from baseline to day 5 after interventions
timeFrame: up to 5 days after baseline
measure: Change in the preoperative leg circumference on the 7th day of surgery
timeFrame: up to 7 days after surgery
measure: Change in leg circumference from day 7 to day 14 post-surgery
timeFrame: up to 14 days after surgery
measure: Change in leg circumference from day 14 to day 21 post-surgery
timeFrame: up to 21 days after surgery
measure: Baseline range of motion
timeFrame: baseline
measure: Change in range of motion from baseline to day 5 after interventions
timeFrame: up to 5 days after baseline
measure: Change in the preoperative range of motion on the 7th day of surgery
timeFrame: up to 7 days after surgery
measure: Change in range of motion from day 7 to day 14 post-surgery
timeFrame: up to 14 days after surgery
measure: Change in range of motion from day 14 to day 21 post-surgery
timeFrame: up to 21 days after surgery
measure: Baseline muscle strength
timeFrame: baseline
measure: Change in muscle strength from baseline to day 5 after interventions
timeFrame: up to 5 days after baseline
measure: Change in the preoperative muscle strength on the 7th day of surgery
timeFrame: up to 7 days after surgery
measure: Change in muscle strength from day 7 to day 14 post-surgery
timeFrame: up to 14 days after surgery
measure: Change in muscle strength from day 14 to day 21 post-surgery
timeFrame: up to 21 days after surgery
measure: Baseline skin temperature
timeFrame: baseline
measure: Change in skin temperature from baseline to day 5 after interventions
timeFrame: up to 5 days after baseline
measure: Change in the preoperative skin temperature on the 7th day of surgery
timeFrame: up to 7 days after surgery
measure: Change in skin temperature from day 7 to day 14 post-surgery
timeFrame: up to 14 days after surgery
measure: Change in skin temperature from day 14 to day 21 post-surgery
timeFrame: up to 21 days after surgery
measure: Baseline knee proprioception
timeFrame: baseline
measure: Change in knee proprioception from baseline to day 5 after interventions
timeFrame: up to 5 days after baseline
measure: Change in the preoperative knee proprioception on the 7th day of surgery
timeFrame: up to 7 days after surgery
measure: Change in knee proprioception from day 7 to day 14 post-surgery
timeFrame: up to 14 days after surgery
measure: Change in knee proprioception from day 14 to day 21 post-surgery
timeFrame: up to 21 days after surgery
measure: Baseline Time Up and Go
timeFrame: baseline
measure: Change in Time Up and Go from baseline to day 5 after interventions
timeFrame: up to 5 days after baseline
measure: Change in the preoperative Time Up and Go on the 7th day of surgery
timeFrame: up to 7 days after surgery
measure: Change in Time Up and Go from day 7 to day 14 post-surgery
timeFrame: up to 14 days after surgery
measure: Change in Time Up and Go from day 14 to day 21 post-surgery
timeFrame: up to 21 days after surgery
Secondary outcomes:
measure: SF-36
timeFrame: baseline
measure: Change in the preoperative SF-36 on the 21st day of surgery
timeFrame: up to 21 days after surgery
measure: WOMAC
timeFrame: before interventions, 21st day after surgery
measure: Change in the preoperative WOMAC on the 21st day of surgery
timeFrame: up to 21 days after surgery
measure: Global Rating of Change Scales (GROC)
timeFrame: up to 21st day after surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Zeynep Hazar
role: STUDY_DIRECTOR
affiliation: Gulhane Training and Research Hospital
name: Cemil Yıldız
role: STUDY_CHAIR
affiliation: Gazi University
name: Sevim Beyza Ölmez
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Beyza Yazgan
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: İnci Ayaş
role: PRINCIPAL_INVESTIGATOR
References: