Protocol summary
-
Study aim
-
Determining and comparing the effect of TECAR therapy and physiotherapy in improving the symptoms and performance of patients with knee osteoarthritis
-
Design
-
A randomized controlled, parallel-group, single-blinded, phase 3 clinical trial of 46 patients
-
Settings and conduct
-
The present study will be conducted in physical medicine and rehabilitation clinic of Amin Hospital of Isfahan University of Medical Sciences in 2023-2024. The patients are divided into two groups, A and B, performing classical physiotherapy intervention and TECAR therapy, respectively. Functional status is measured based on WOMAC questionnaire and pain intensity based on VAS questionnaire immediately after treatment, 1 month later and 3 months later. Comparisons in two groups are made based on primary variables with the help of independent t-tests or chi-score for quantitative and qualitative variables, respectively. All analyzes are performed at the 5% error level and with the help of SPSS24 software.
-
Participants/Inclusion and exclusion criteria
-
Diagnosis of knee osteoarthritis by physical therapist and grades 2 and 3 of knee osteoarthritis based on Kellgren-Lawrence radiological grading; age 40 to 80 years; duration of pain more than one month; VAS pain score of at least 3; informed written consent to participate in the study
-
Intervention groups
-
Group A receives standard physiotherapy treatment, which includes IR, TENS, HP. The number of physiotherapy sessions is 10 sessions every other day for 60 minutes in the physiotherapy center of Amin Hospital of Isfahan University of Medical Sciences.
In group B, TECAR therapy is performed using the WINBACK device, made in France, in the physiotherapy department of Amin Hospital, and the number of sessions is 6 twice a week.
-
Main outcome variables
-
Functional status based on WOMAC questionnaire, pain intensity based on VAS questionnaire
General information
-
Reason for update
-
wrong entrance of Kellgren-Lawrence grades including criterion and number of patients
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20190618043931N5
Registration date:
2024-03-01, 1402/12/11
Registration timing:
registered_while_recruiting
Last update:
2024-12-22, 1403/10/02
Update count:
1
-
Registration date
-
2024-03-01, 1402/12/11
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2023-08-23, 1402/06/01
-
Expected recruitment end date
-
2024-04-20, 1403/02/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Study and comparison of the Effect of TECAR Therapy and physiotherapy in the Symptoms and Functions of the Patients with Knee Osteoarthritis
-
Public title
-
Study and comparison of the Effect of TECAR Therapy and physiotherapy in the Symptoms and Functions of the Patients with Knee Osteoarthritis
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Diagnosis of knee joint osteoarthritis by a physical therapist and selecting patients with moderate to severe knee osteoarthritis based on physical examination and grades 2 and 3 osteoarthritis based on the Kellgren-Lawrence radiographic grading.
Duration of knee pain over 1 month
VAS score of at least 3
Written informed consent for participation in study
Exclusion criteria:
Contraindications of TECAR device such as pregnancy, pacemaker, cancer, open wounds, skin lesions, skin sensitivity and lack of heat perception
No written informed consent
Hyaluronic acid injections during the past 6 months or steroid injection 6 weeks before entry
-
Age
-
From 40 years old to 80 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
-
Sample size
-
Target sample size:
46
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Patients who will included in the study, will be randomly assigned to one of the two intervention groups. The randomization method is to generate 23 random numbers from 1 to 46 by Excel software to be assigned to the first intervention group and then assigning the remaining 23 numbers to the second intervention group.
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
The person who analyses the data is someone other than the researcher and is kept blind and unaware of the interventional groups.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2024-02-21, 1402/12/02
-
Ethics committee reference number
-
IR.MUI.MED.REC.1402.444
Health conditions studied
1
-
Description of health condition studied
-
Osteoarthritis of knee
-
ICD-10 code
-
M17
-
ICD-10 code description
-
Osteoarthritis of knee
Primary outcomes
1
-
Description
-
Functional status based on WOMAC questionnaire
-
Timepoint
-
Immediately after treatment, 1 month later, 3 months later
-
Method of measurement
-
WOMAC questionnaire
2
-
Description
-
Pain level
-
Timepoint
-
Functional status based on WOMAC questionnaire
-
Method of measurement
-
VAS
Intervention groups
1
-
Description
-
Intervention group: In this group, TECAR therapy is performed using the WINBACK device, made in France, in the physiotherapy department of Amin Hospital, and the number of sessions is 6 twice a week.
-
Category
-
Rehabilitation
2
-
Description
-
Control group: receive standard physiotherapy treatment, which includes IR, TENS, HP. The number of physiotherapy sessions is 10 sessions every other day for 60 minutes in the physiotherapy center of Amin Hospital of Isfahan University of Medical Sciences.
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Esfahan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
All data is potentially shareable after de-identifying individuals
-
When the data will become available and for how long
-
The access period starts from 2024
-
To whom data/document is available
-
anyone
-
Under which criteria data/document could be used
-
-
-
From where data/document is obtainable
-
Pooria Yeganeh Fard - 09178085110
-
What processes are involved for a request to access data/document
-
-
-
Comments
-