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Protocol summary
Aim is comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis attending to Imam-Reza Hospital in 2018
Aim is comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis attending to Imam-Reza Hospital in 2019-2020
Aim is comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis attending to Imam-Reza Hospital in 20182019-2020
هدف مقایسه tDCS و Sham tDCS در کاهش درد استئوآرتریت زانو در مراجعین به بیمارستان امام رضا در سال 97 بوده است.
هدف مقایسه tDCS و Sham tDCS در کاهش درد استئوآرتریت زانو در مراجعین به بیمارستان امام رضا در سال 97-98 بوده است.
هدف مقایسه tDCS و Sham tDCS در کاهش درد استئوآرتریت زانو در مراجعین به بیمارستان امام رضا در سال 97-98 بوده است.
Clinical trial with a control group with parallel groups, non blind, randomized.
Clinical trial with a control group with parallel groups, single-blind, randomized.
Clinical trial with a control group with parallel groups, non single-blind, randomized.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، کور نشده و تصادفی شده می باشد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سو کور شده و تصادفی شده می باشد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سو کور نشدهشده و تصادفی شده می باشد.
This study was conducted as a clinical trial in Imam Reza Hospital and in patients with knee osteoarthritis, this is a non blind study in which patients will blinded. This is in phase 4 and in this 54 patients with a block method are divided into two groups, 27 patients in first intervention group and receive tDCS, and 27 patients in second intervention group receiving Sham tDCS. Based on this, at first and three month after starting treatment, pain of patients will assessed.
This study was conducted as a clinical trial in Imam Reza Hospital and in patients with knee osteoarthritis, this is a single-blind study in which patients will blinded. This is in phase 4 and in this 54 patients with a block method are divided into two groups, 27 patients in first intervention group and receive tDCS, and 27 patients in second intervention group receiving Sham tDCS. Based on this, at first and three month after starting treatment, pain of patients will assessed.
This study was conducted as a clinical trial in Imam Reza Hospital and in patients with knee osteoarthritis, this is a non single-blind study in which patients will blinded. This is in phase 4 and in this 54 patients with a block method are divided into two groups, 27 patients in first intervention group and receive tDCS, and 27 patients in second intervention group receiving Sham tDCS. Based on this, at first and three month after starting treatment, pain of patients will assessed.
این مطالعه به صورت کارازمایی بالینی در بیمارستان امام رضا و بر روی بیماران مبتلا به استئوارتریت زانو انجام می شود، این مطالعه به صورت کور نشده خواهد بود که در آن برای بیماران انجام مطالعه کور خواهد شد. این ارزیابی در فاز 4 بوده و در آن 54 بیمار با روش بلاکی در دو دسته قرار می گیرند، 27 بیمار در گروه مداخله اول و دریافت کننده tDCS و 27 بیمار در گروه مداخله دوم و دریافت کننده Sham tDCS قرار می گیرند. بر این اساس در ابتدا و 3 ماه بعد از درمان وضعیت درد در بیماران ارزیابی می شود.
این مطالعه به صورت کارازمایی بالینی در بیمارستان امام رضا و بر روی بیماران مبتلا به استئوارتریت زانو انجام می شود، این مطالعه به صورت یک سو کور شده خواهد بود که در آن برای بیماران انجام مطالعه کور خواهد شد. این ارزیابی در فاز 4 بوده و در آن 54 بیمار با روش بلاکی در دو دسته قرار می گیرند، 27 بیمار در گروه مداخله اول و دریافت کننده tDCS و 27 بیمار در گروه مداخله دوم و دریافت کننده Sham tDCS قرار می گیرند. بر این اساس در ابتدا و 3 ماه بعد از درمان وضعیت درد در بیماران ارزیابی می شود.
این مطالعه به صورت کارازمایی بالینی در بیمارستان امام رضا و بر روی بیماران مبتلا به استئوارتریت زانو انجام می شود، این مطالعه به صورت یک سو کور نشدهشده خواهد بود که در آن برای بیماران انجام مطالعه کور خواهد شد. این ارزیابی در فاز 4 بوده و در آن 54 بیمار با روش بلاکی در دو دسته قرار می گیرند، 27 بیمار در گروه مداخله اول و دریافت کننده tDCS و 27 بیمار در گروه مداخله دوم و دریافت کننده Sham tDCS قرار می گیرند. بر این اساس در ابتدا و 3 ماه بعد از درمان وضعیت درد در بیماران ارزیابی می شود.
General information
Not blinded
Single blinded
notblsingl
1
1
Not used
Used
nusedused
3
N/A
3na
2020-01-20, 1398/10/30
2020-01-27, 1398/11/07
2020-01-2027 00:00:00
2020-08-21, 1399/05/31
2020-04-19, 1399/01/31
2020-0804-2119 00:00:00
empty
The dates had been erroneously typed.
Blinding statement had been written in the section Randomization.
The randomization protocol had been written as "simple" (Now, it has been corrected into "block")
We consider a placebo-sham control group in our study.
The dates had been erroneously typed. Blinding statement had been written in the section Randomization. The randomization protocol had been written as "simple" (Now, it has been corrected into "block") We consider a placebo-sham control group in our study.
empty
تاریخ ها به اشتباه وارد شده بود.
کورسازی اشتباها در بخش تصادفی سازی ذکر شده بود.
نوع تصادفی سازی اشتباها "ساده" عنوان شده بود (به "بلوکی" تصحیح شد)
مطالعه حاضر دارای گروه کنترل پلاسبو (گروه شم) می باشد.
تاریخ ها به اشتباه وارد شده بود. کورسازی اشتباها در بخش تصادفی سازی ذکر شده بود. نوع تصادفی سازی اشتباها "ساده" عنوان شده بود (به "بلوکی" تصحیح شد) مطالعه حاضر دارای گروه کنترل پلاسبو (گروه شم) می باشد.
Comparison of two methods in pain relief of knee osteoarthritis
The effects of tDCS for pain relief of knee osteoarthritis
ComparisonThe effects of two methods intDCS for pain relief of knee osteoarthritis
مقایسه دو روش در کاهش درد ناشی از استئوآرتریت زانو
بررسی تاثیر tDCS در کاهش درد ناشی از استئوآرتریت زانو
مقایسه دو روشبررسی تاثیر tDCS در کاهش درد ناشی از استئوآرتریت زانو
Comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis attending to Imam-Reza Hospital in 2018
Comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis
Comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis attending to Imam-Reza Hospital in 2018
مقایسه tDCS و Sham tDCS در کاهش درد استئوآرتریت زانو در مراجعین به بیمارستان امام رضا در سال 97
مقایسه tDCS و Sham tDCS در کاهش درد استئوآرتریت زانو
مقایسه tDCS و Sham tDCS در کاهش درد استئوآرتریت زانو در مراجعین به بیمارستان امام رضا در سال 97
A simple randomization is done with sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B they will be tested.
We use block randomization to ensure that the two groups are of the same size. Patients are randomized by blocked randomization of size two or four to the two groups of active or sham tDCS. Random numbers are generated in an independent statistical room using a computer. The units of randomization are individuals. There is no stratification in the randomization process.
A simpleWe use block randomization is done with sealed envelope tools in such a wayto ensure that the letters A and Btwo groups are insertedof the same size. Patients are randomized by blocked randomization of size two or four to the two groups of active or sham tDCS. Random numbers are generated in an independent statistical room using a computer. The units of randomization are individuals. There is no stratification in the envelopes and patients are asked to select an envelope that the intervention group A and the group B they will be testedrandomization process.
تصادفی سازی ساده فردی با ابزار پاکت های مهر و موم شده انجام می شود به این صورت که داخل پاکت ها حروف الف و ب نوشته می شود و از بیماران درخواست می شود یک پاکت را انتخاب کنند که گروه الف گروه مداخله و گروه ب گروه آزمون خواهند بود.
ما از تصادفی سازی بلوکی به منظور جدا سازی دو گروه با سایز مساوی استفاده می کنیم. بیماران با بلوک های 2 یا 4 تایی به دو گروه tDCS فعال یا شم اختصاص می یابند. اعداد تصادفی در یک اطاق آمار غیروابسته به این تحقیق ایجاد خواهد شد. واحد تصادفی سازی افراد می باشند. در پروسه تصادفی سازی از لایه سازی استفاده نمی شود.
ما از تصادفی سازی ساده فردیبلوکی به منظور جدا سازی دو گروه با ابزار پاکتسایز مساوی استفاده می کنیم. بیماران با بلوک های مهر و موم شده انجام2 یا 4 تایی به دو گروه tDCS فعال یا شم اختصاص می شودیابند. اعداد تصادفی در یک اطاق آمار غیروابسته به این صورت که داخل پاکت ها حروف الف و ب نوشتهتحقیق ایجاد خواهد شد. واحد تصادفی سازی افراد می شود وباشند. در پروسه تصادفی سازی از بیماران درخواست میلایه سازی استفاده نمی شود یک پاکت را انتخاب کنند که گروه الف گروه مداخله و گروه ب گروه آزمون خواهند بود.
Our study is a single-blind randomized trial. The participants will be unaware of the sham or active treatment they would receive throughout the study. The investigators and clinicians are not masked to the patients' group assignment.
Our study is a single-blind randomized trial. The participants will be unaware of the sham or active treatment they would receive throughout the study. The investigators and clinicians are not masked to the patients' group assignment.
مطالعه ما کارآزمایی بالینی از نوع یک سو کور می باشد. بیماران از فعال، یا شم بودن tDCS مطلع نخواهند بود. اما کلینیسین ها و ارزیابان از عضویت گروه هربیمار مطلع می باشند.
مطالعه ما کارآزمایی بالینی از نوع یک سو کور می باشد. بیماران از فعال، یا شم بودن tDCS مطلع نخواهند بود. اما کلینیسین ها و ارزیابان از عضویت گروه هربیمار مطلع می باشند.
Recruitment centers
#1
Name of recruitment center - English: Imam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا (ع)
Full name of responsible person - English: Bahare Mohebi
Full name of responsible person - Persian: بهاره محبی
Street address - English: 1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Fax:
Email: behar.moheb@gmail.com
Web page address:
Name of recruitment center - English: Imam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا (ع)
Full name of responsible person - English: Bahare Mohebi
Full name of responsible person - Persian: بهاره محبی
Street address - English: 1411718541, Aja University of Medical Medical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Fax:
Email: behar.moheb@gmail.com
Web page address:
Name of recruitment center - English: Imam Reza Hospital Name of recruitment center - Persian: بیمارستان امام رضا (ع) Full name of responsible person - English: Bahare Mohebi Full name of responsible person - Persian: بهاره محبی Street address - English: 1411718541, MedicalAja University for the Islamic Republic of Iran's ArmyMedical Medical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411718541 Phone: +98 21 8609 6350 Fax: Email: behar.moheb@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mostafa Shahrezaee
Full name of responsible person - Persian: مصطفی شاهرضایی
Street address - English: 1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Fax:
Email: moshahrezayee@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mostafa Shahrezaee
Full name of responsible person - Persian: مصطفی شاهرضایی
Street address - English: 1411718541, Aja Medical University, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Fax:
Email: moshahrezayee@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mostafa Shahrezaee Full name of responsible person - Persian: مصطفی شاهرضایی Street address - English: 1411718541, Aja Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411718541 Phone: +98 21 8609 6350 Fax: Email: moshahrezayee@yahoo.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Bahare Mohebi
Full name of responsible person - Persian: بهاره محبی
Position - English: Resident of Physical Medicine and Rehabilitation
Position - Persian: دستیار تخصص طب فیزیکی و توانبخشی
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Mobile: +98 913 270 3552
Fax:
Email: behar.moheb@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Bahare Mohebi
Full name of responsible person - Persian: بهاره محبی
Position - English: Resident of Physical Medicine and Rehabilitation
Position - Persian: دستیار تخصص طب فیزیکی و توانبخشی
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 1411718541, Aja University of Medical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Mobile: +98 913 270 3552
Fax:
Email: behar.moheb@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Bahare Mohebi Full name of responsible person - Persian: بهاره محبی Position - English: Resident of Physical Medicine and Rehabilitation Position - Persian: دستیار تخصص طب فیزیکی و توانبخشی Latest degree: med_doctor Area of specialty/work: 59 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 1411718541, MedicalAja University for the Islamic Republic of Iran's ArmyMedical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1411718541 Phone: +98 21 8609 6350 Mobile: +98 913 270 3552 Fax: Email: behar.moheb@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Bahare Mohebi
Full name of responsible person - Persian: بهاره محبی
Position - English: Resident of Physical Medicine and Rehabilitation
Position - Persian: دستیار تخصص طب فیزیکی و توانبخشی
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Mobile: +98 913 270 3552
Fax:
Email: behar.moheb@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Bahare Mohebi
Full name of responsible person - Persian: بهاره محبی
Position - English: Resident of Physical Medicine and Rehabilitation
Position - Persian: دستیار تخصص طب فیزیکی و توانبخشی
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 1411718541, Aja University of Medical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Mobile: +98 913 270 3552
Fax:
Email: behar.moheb@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Bahare Mohebi Full name of responsible person - Persian: بهاره محبی Position - English: Resident of Physical Medicine and Rehabilitation Position - Persian: دستیار تخصص طب فیزیکی و توانبخشی Latest degree: med_doctor Area of specialty/work: 59 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 1411718541, MedicalAja University for the Islamic Republic of Iran's ArmyMedical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1411718541 Phone: +98 21 8609 6350 Mobile: +98 913 270 3552 Fax: Email: behar.moheb@gmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Bahare Mohebi
Full name of responsible person - Persian: بهاره محبی
Position - English: Resident of Physical Medicine and Rehabilitation
Position - Persian: دستیار تخصص طب فیزیکی و توانبخشی
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Mobile: +98 913 270 3552
Fax:
Email: behar.moheb@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Bahare Mohebi
Full name of responsible person - Persian: بهاره محبی
Position - English: Resident of Physical Medicine and Rehabilitation
Position - Persian: دستیار تخصص طب فیزیکی و توانبخشی
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 1411718541, Aja University of Medical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6350
Mobile: +98 913 270 3552
Fax:
Email: behar.moheb@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Bahare Mohebi Full name of responsible person - Persian: بهاره محبی Position - English: Resident of Physical Medicine and Rehabilitation Position - Persian: دستیار تخصص طب فیزیکی و توانبخشی Latest degree: med_doctor Area of specialty/work: 59 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 1411718541, MedicalAja University for the Islamic Republic of Iran's ArmyMedical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran Street address - Persian: ایران، تهران، خیابان فاطمی غربی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش، 1411718541 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1411718541 Phone: +98 21 8609 6350 Mobile: +98 913 270 3552 Fax: Email: behar.moheb@gmail.com Web page address:
Protocol summary
Study aim
Aim is comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis attending to Imam-Reza Hospital in 2019-2020
Design
Clinical trial with a control group with parallel groups, single-blind, randomized.
Settings and conduct
This study was conducted as a clinical trial in Imam Reza Hospital and in patients with knee osteoarthritis, this is a single-blind study in which patients will blinded. This is in phase 4 and in this 54 patients with a block method are divided into two groups, 27 patients in first intervention group and receive tDCS, and 27 patients in second intervention group receiving Sham tDCS. Based on this, at first and three month after starting treatment, pain of patients will assessed.
Participants/Inclusion and exclusion criteria
Patients with knee osteoarthritis, age between 20 to 70 years, pain over 6 months, VAS between 3 and 7 and Being able to express the intensity of pain will included in study, also patents with a metal or device in the head, carbamazepine use in the last 6 months, drug addiction, alcohol consumption in the last 6 months, history of neurological diseases, history of neurosurgery and a history of severe depression will excluded from study.
Intervention groups
In first group, stimulation will performed using transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 20 minutes, and in another stimulation will performed using Sham transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 30 seconds.
Main outcome variables
Pain of Knee Osteoarthritis
General information
Reason for update
The dates had been erroneously typed.
Blinding statement had been written in the section Randomization.
The randomization protocol had been written as "simple" (Now, it has been corrected into "block")
We consider a placebo-sham control group in our study.
Acronym
IRCT registration information
IRCT registration number:IRCT20191214045724N1
Registration date:2020-02-02, 1398/11/13
Registration timing:registered_while_recruiting
Last update:2020-06-26, 1399/04/06
Update count:1
Registration date
2020-02-02, 1398/11/13
Registrant information
Name
Bahar Mohebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 6637 3737
Email address
behar.moheb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-27, 1398/11/07
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis
Public title
The effects of tDCS for pain relief of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 70 years
Pain over 6 months
VAS between 3 and 7
Being able to express the intensity of pain
Exclusion criteria:
A metal or device in the head
Carbamazepine use in the last 6 months
Drug addiction
Alcohol consumption in the last 6 months
History of neurological diseases
History of Neurosurgery
A history of severe depression
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
We use block randomization to ensure that the two groups are of the same size. Patients are randomized by blocked randomization of size two or four to the two groups of active or sham tDCS. Random numbers are generated in an independent statistical room using a computer. The units of randomization are individuals. There is no stratification in the randomization process.
Blinding (investigator's opinion)
Single blinded
Blinding description
Our study is a single-blind randomized trial. The participants will be unaware of the sham or active treatment they would receive throughout the study. The investigators and clinicians are not masked to the patients' group assignment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
Tehran, West Fatemi St., Etemadzadeh Avenue, Aja University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1411718541
Approval date
2020-01-26, 1398/11/06
Ethics committee reference number
IR.AJAUMS.REC.1398.233
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain of Knee Osteoarthritis
Timepoint
Instantly and 3 months after treatment
Method of measurement
Based on Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, stimulation was performed using transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 20 minutes.
Category
Rehabilitation
2
Description
Intervention group: In this group, stimulation was performed using Sham transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 30 seconds.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Bahare Mohebi
Street address
1411718541, Aja University of Medical Medical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
behar.moheb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mostafa Shahrezaee
Street address
1411718541, Aja Medical University, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
moshahrezayee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Bahare Mohebi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
1411718541, Aja University of Medical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
behar.moheb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Bahare Mohebi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
1411718541, Aja University of Medical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
behar.moheb@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Bahare Mohebi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
1411718541, Aja University of Medical Sciences, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
behar.moheb@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available