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Protocol summary
A randomized controlled, parallel-group, single-blinded, phase 3 clinical trial of 50 patients
A randomized controlled, parallel-group, single-blinded, phase 3 clinical trial of 46 patients
A randomized controlled, parallel-group, single-blinded, phase 3 clinical trial of 5046 patients
کارآزمایی بالینی دارای گروه کنترل، تصادفی سازی شده با گروه های موازی، یک سو کور، فاز 3 بر روی 50 بیمار
کارآزمایی بالینی دارای گروه کنترل، تصادفی سازی شده با گروه های موازی، یک سو کور، فاز 3 بر روی 46 بیمار
کارآزمایی بالینی دارای گروه کنترل، تصادفی سازی شده با گروه های موازی، یک سو کور، فاز 3 بر روی 5046 بیمار
The present study will be conducted in physical medicine and rehabilitation clinic of Amin Hospital of Isfahan University of Medical Sciences in 2014-2015. 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.
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.
The present study will be conducted in physical medicine and rehabilitation clinic of Amin Hospital of Isfahan University of Medical Sciences in 20142023-20152024. 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.
Diagnosis of knee osteoarthritis by physical therapist and grades 3 and 4 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
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
Diagnosis of knee osteoarthritis by physical therapist and grades 32 and 43 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
تشخیص استئوآرتریت زانو توسط متخصص طب فیزیکی و توانبخشی و انتخاب افراد دارای استئوآرتریت زانوی moderate و severe بر اساس معاینه و گریدهای 3 و 4 استئوآرتریت زانو بر اساس گریدینگ رادیوگرافی kellgren – Lawrence؛ سن 40 تا 80 سال؛ طول مدت درد بیش از یک ماه؛ نمره درد VAS حداقل 3؛ رضایت کتبی آگاهانه برای شرکت در مطالعه
تشخیص استئوآرتریت زانو توسط متخصص طب فیزیکی و توانبخشی و انتخاب افراد دارای استئوآرتریت زانوی moderate و severe بر اساس معاینه و گریدهای 2 و 3 استئوآرتریت زانو بر اساس گریدینگ رادیوگرافی kellgren – Lawrence؛ سن 40 تا 80 سال؛ طول مدت درد بیش از یک ماه؛ نمره درد VAS حداقل 3؛ رضایت کتبی آگاهانه برای شرکت در مطالعه
تشخیص استئوآرتریت زانو توسط متخصص طب فیزیکی و توانبخشی و انتخاب افراد دارای استئوآرتریت زانوی moderate و severe بر اساس معاینه و گریدهای 32 و 43 استئوآرتریت زانو بر اساس گریدینگ رادیوگرافی kellgren – Lawrence؛ سن 40 تا 80 سال؛ طول مدت درد بیش از یک ماه؛ نمره درد VAS حداقل 3؛ رضایت کتبی آگاهانه برای شرکت در مطالعه
General information
50
46
5046
empty
wrong entrance of Kellgren-Lawrence grades including criterion and number of patients
wrong entrance of Kellgren-Lawrence grades including criterion and number of patients
empty
اشتباه تایپی در ورود اعداد در معیارهای ورود Kellgren-Lawrence و تعداد نمونه
اشتباه تایپی در ورود اعداد در معیارهای ورود Kellgren-Lawrence و تعداد نمونه
Diagnosis of knee joint osteoarthritis by a physical therapist and selecting patients with moderate to severe knee osteoarthritis based on physical examination and grades 3 and 4 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
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
Diagnosis of knee joint osteoarthritis by a physical therapist and selecting patients with moderate to severe knee osteoarthritis based on physical examination and grades 32 and 43 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
تشخیص استئوآرتریت زانو توسط متخصص طب فیزیکی و توانبخشی انتخاب افراد دارای استئوآرتریت زانوی moderate و severe بر اساس معاینه و گریدهای 3 و 4 استئوآرتریت زانو بر اساس گریدینگ رادیوگرافی Kellgren-Lawrence
طول مدت درد بیش از یک ماه
نمره درد VAS حداقل 3
رضایت کتبی آگاهانه برای شرکت در مطالعه
تشخیص استئوآرتریت زانو توسط متخصص طب فیزیکی و توانبخشی انتخاب افراد دارای استئوآرتریت زانوی moderate و severe بر اساس معاینه و گریدهای 2 و 3 استئوآرتریت زانو بر اساس گریدینگ رادیوگرافی Kellgren-Lawrence
طول مدت درد بیش از یک ماه
نمره درد VAS حداقل 3
رضایت کتبی آگاهانه برای شرکت در مطالعه
تشخیص استئوآرتریت زانو توسط متخصص طب فیزیکی و توانبخشی انتخاب افراد دارای استئوآرتریت زانوی moderate و severe بر اساس معاینه و گریدهای 32 و 43 استئوآرتریت زانو بر اساس گریدینگ رادیوگرافی Kellgren-Lawrence طول مدت درد بیش از یک ماه نمره درد VAS حداقل 3 رضایت کتبی آگاهانه برای شرکت در مطالعه
Patients who will included in the study, will be randomly assigned to one of the two intervention groups. The randomization method is to generate 25 random numbers from 1 to 50 by Excel software to be assigned to the first intervention group and then assigning the remaining 25 numbers to the second intervention group.
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.
Patients who will included in the study, will be randomly assigned to one of the two intervention groups. The randomization method is to generate 2523 random numbers from 1 to 5046 by Excel software to be assigned to the first intervention group and then assigning the remaining 2523 numbers to the second intervention group.
بیمارانی که وارد مطالعه خواهند شد به صورت تصادفی در یکی از دو گروه مداخله قرار خواهند گرفت. روش تصادفی سازی به این صورت است که 25 عدد تصادفی از 1 تا 50 توسط نرم افزار اکسل ایجاد می شود که به گروه مداخله اول اختصاص داده می شود و سپس 25 عدد باقی مانده به گروه مداخله دوم اختصاص داده می شود.
بیمارانی که وارد مطالعه خواهند شد به صورت تصادفی در یکی از دو گروه مداخله قرار خواهند گرفت. روش تصادفی سازی به این صورت است که 23 عدد تصادفی از 1 تا 46 توسط نرم افزار اکسل ایجاد می شود که به گروه مداخله اول اختصاص داده می شود و سپس 23 عدد باقی مانده به گروه مداخله دوم اختصاص داده می شود.
بیمارانی که وارد مطالعه خواهند شد به صورت تصادفی در یکی از دو گروه مداخله قرار خواهند گرفت. روش تصادفی سازی به این صورت است که 2523 عدد تصادفی از 1 تا 5046 توسط نرم افزار اکسل ایجاد می شود که به گروه مداخله اول اختصاص داده می شود و سپس 2523 عدد باقی مانده به گروه مداخله دوم اختصاص داده می شود.
Recruitment centers
#1
Name of recruitment center - English: Physical Therapy Clinic of Amin Hospital
Name of recruitment center - Persian: درمانگاه طب فیزیکی بیمارستان امین
Full name of responsible person - English: دکتر شیلا حقیقت
Full name of responsible person - Persian: Dr. Shila Haghighat
Street address - English: Sonbolestan st.
Street address - Persian: خیابان سنبلستان
City - English: اصفهان
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8148653141
Phone: +98 31 3445 5051
Fax:
Email: aminhospital@mui.com
Web page address:
Name of recruitment center - English: Physical Therapy Clinic of Amin Hospital
Name of recruitment center - Persian: درمانگاه طب فیزیکی بیمارستان امین
Full name of responsible person - English: Dr. Shila Haghighat
Full name of responsible person - Persian: دکتر شیلا حقیقت
Street address - English: Amin Hospital, Sonbolestan St., Ebnesina Ave., Shohada Sq.
Street address - Persian: فلکه شهدا -خیابان ابن سینا -خیابان سنبلستان -مرکز آموزشی درمانی امین
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8148653141
Phone: +98 31 3445 5051
Fax:
Email: aminhospital@mui.ac.ir
Web page address:
Name of recruitment center - English: Physical Therapy Clinic of Amin Hospital Name of recruitment center - Persian: درمانگاه طب فیزیکی بیمارستان امین Full name of responsible person - English: دکتر شیلا حقیقتDr. Shila Haghighat Full name of responsible person - Persian: Dr. Shila Haghighatدکتر شیلا حقیقت Street address - English: Amin Hospital, Sonbolestan stSt., Ebnesina Ave., Shohada Sq. Street address - Persian: فلکه شهدا -خیابان ابن سینا -خیابان سنبلستان -مرکز آموزشی درمانی امین City - English: اصفهانIsfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8148653141 Phone: +98 31 3445 5051 Fax: Email: aminhospital@mui.commui.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Marjan Mortazavi
Full name of responsible person - Persian: دکتر مرجان مرتضوی
Street address - English: Medicine department, Isfahan university, Hezar Jarib St
Street address - Persian: خبایان هزارجریب، دانشگاه اصفهان، دانشکده پزشکی
City - English: اصفهان
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81746-73461
Phone: +98 31 3668 7898
Fax:
Email: research@mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Marjan Mortazavi
Full name of responsible person - Persian: دکتر مرجان مرتضوی
Street address - English: Medicine department, Isfahan university, Hezar Jarib St
Street address - Persian: خبایان هزارجریب، دانشگاه اصفهان، دانشکده پزشکی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81746-73461
Phone: +98 31 3668 7898
Fax:
Email: research@mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Marjan Mortazavi Full name of responsible person - Persian: دکتر مرجان مرتضوی Street address - English: Medicine department, Isfahan university, Hezar Jarib St Street address - Persian: خبایان هزارجریب، دانشگاه اصفهان، دانشکده پزشکی City - English: اصفهانIsfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81746-73461 Phone: +98 31 3668 7898 Fax: Email: research@mui.ac.ir Web page address:
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
Name
Shila Haghighat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 5139
Email address
shila_haghighat@med.mui.ac.ir
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
Isfahan
Province
Isfehan
Postal code
8174673461
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
Secondary outcomes
empty
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.