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General information
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The name of Shahid Rajaei Hospital of Babol University of Medical Sciences as one of the recruitment centers from the beginning in the process of registering the project protocol in the Iranian Registry of Clinical Trials and its approval in the ethical committee of that institution before the study, the code obtained from the ethics committee not mentioned in the Iranian Registry of Clinical Trials, which is corrected now in the research data on the the Iranian Registry of Clinical Trials.
The name of Shahid Rajaei Hospital of Babol University of Medical Sciences as one of the recruitment centers from the beginning in the process of registering the project protocol in the Iranian Registry of Clinical Trials and its approval in the ethical committee of that institution before the study, the code obtained from the ethics committee not mentioned in the Iranian Registry of Clinical Trials, which is corrected now in the research data on the the Iranian Registry of Clinical Trials.
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نام بیمارستان شهید رجایی دانشگاه علوم پزشکی بابل به عنوان یکی از مراکز بیمارگیری از ابتدا در فرایند ثبت پروتکل طرح در سامانه ثبت کارآزمایی بالینی ایران و تایید پروتکل طرح در کمیته اخلاق سازمانی آن نهاد پیش از شروع مطالعه، کد اخذ شده از کمیته اخلاق دانشگاه علوم پزشکی بابل در سامانه ثبت کارآزمایی بالینی ایران ذکر نشده بود که بدین وسیله اطلاعات طرح در سامانه ثبت کارآزمایی بالینی ایران به روز رسانی شد.
نام بیمارستان شهید رجایی دانشگاه علوم پزشکی بابل به عنوان یکی از مراکز بیمارگیری از ابتدا در فرایند ثبت پروتکل طرح در سامانه ثبت کارآزمایی بالینی ایران و تایید پروتکل طرح در کمیته اخلاق سازمانی آن نهاد پیش از شروع مطالعه، کد اخذ شده از کمیته اخلاق دانشگاه علوم پزشکی بابل در سامانه ثبت کارآزمایی بالینی ایران ذکر نشده بود که بدین وسیله اطلاعات طرح در سامانه ثبت کارآزمایی بالینی ایران به روز رسانی شد.
Ethics committees
#1
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2021-01-23, 1399/11/04
2021-01-23 00:00:00
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IR.MUBABOL.REC.1399.453
IR.MUBABOL.REC.1399.453
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Alireza Javadinia
Full name of responsible person - Persian: سید علیرضا جوادی نیا
Position - English: Consultant
Position - Persian: پزشک متخصص غیر هیئت علمی
Latest degree: specialist
Area of specialty/work: 45
Area of specialty/work title - English: Oncology
Area of specialty/work title - Persian: انکولوژی
Street address - English: Radiotherapy ward, Vasei Hospital, Shohaeye Hasteii BLV.
Street address - Persian: بخش رادیوتراپی بیمارستان واسعی، بلوار شهدای هسته ای
City - English: Sabzevar
City - Persian: سبزوار
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9617747431
Phone: +98 51 4465 1300
Mobile: +98 915 572 8157
Fax:
Email: javadinia.alireza@gmail.com
Web page address: http://research.mums.ac.ir/webdocument/load.action?webdocument_code=8000&masterCode=8011136
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Alireza Javadinia
Full name of responsible person - Persian: سید علیرضا جوادی نیا
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 45
Area of specialty/work title - English: Oncology
Area of specialty/work title - Persian: انکولوژی
Street address - English: Radiotherapy ward, Vasei Hospital, Shohaeye Hasteii BLV.
Street address - Persian: بخش رادیوتراپی بیمارستان واسعی، بلوار شهدای هسته ای
City - English: Sabzevar
City - Persian: سبزوار
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9617747431
Phone: +98 51 4465 1300
Mobile: +98 915 572 8157
Fax:
Email: javadinia.alireza@gmail.com
Web page address: http://research.mums.ac.ir/webdocument/load.action?webdocument_code=8000&masterCode=8011136
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyed Alireza Javadinia Full name of responsible person - Persian: سید علیرضا جوادی نیا Position - English: ConsultantAssistant Professor Position - Persian: پزشک متخصص غیر هیئت علمیاستادیار Latest degree: specialist Area of specialty/work: 45 Area of specialty/work title - English: Oncology Area of specialty/work title - Persian: انکولوژی Street address - English: Radiotherapy ward, Vasei Hospital, Shohaeye Hasteii BLV. Street address - Persian: بخش رادیوتراپی بیمارستان واسعی، بلوار شهدای هسته ای City - English: Sabzevar City - Persian: سبزوار Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9617747431 Phone: +98 51 4465 1300 Mobile: +98 915 572 8157 Fax: Email: javadinia.alireza@gmail.com Web page address: http://research.mums.ac.ir/webdocument/load.action?webdocument_code=8000&masterCode=8011136
Protocol summary
Study aim
This study will assess the effects of radiotherapy on reduction of severity of pain and improvement of performance score and quality of life in patients with osteoarthritis of knee.
Design
Phase 3 Randomised, placebo controlled, parallel group trial with double blinded outcome assessment on 160 patients. Randomisation will be done by table of random numbers.
Settings and conduct
This study will be performed at radiotherapy units of Vasei Hospital of Sabzevar and Shaid Rajaee Hospital of Babolsar. Patients, physicians and outcome assessor will be blinded regarding the groups of patients.
Participants/Inclusion and exclusion criteria
Patients with osteoarthritis of knee with minimum age of 50 years will be enrolled if they have no pervious history of radiotherapy of affected knee.
Intervention groups
In the intervention group, patients will receive radiotherapy every other day at the daily dose of 0.5 gray for 6 sessions.
Main outcome variables
Severity of pain, performance score, and quality of life of patients will be assessed before and after the intervention.
General information
Reason for update
The name of Shahid Rajaei Hospital of Babol University of Medical Sciences as one of the recruitment centers from the beginning in the process of registering the project protocol in the Iranian Registry of Clinical Trials and its approval in the ethical committee of that institution before the study, the code obtained from the ethics committee not mentioned in the Iranian Registry of Clinical Trials, which is corrected now in the research data on the the Iranian Registry of Clinical Trials.
Acronym
RTOA
IRCT registration information
IRCT registration number:IRCT20160706028815N6
Registration date:2020-12-01, 1399/09/11
Registration timing:prospective
Last update:2022-06-24, 1401/04/03
Update count:1
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
Seyed Alireza Javadinia
Name of organization / entity
Department of Oncology, Omid Hospital, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2736
Email address
javadiniaa941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of low dose radiotherapy on pain relief, performance score, and quality of life in patients with knee joints degenerative disorders
Public title
Effectiveness of radiotherapy on pain, performance score, and quality of life in patients with knee joints osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
knee joints osteoarthritis
Age equal and more than 50 years
Exclusion criteria:
Previous history of radiotherapy of affected joint
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
The table of random numbers will be used for the randomization. Both groups will be matched in term of gender and age. The the envelope method is that the envelopes will be prepared and printed by one of the members of the research team and random numbers will be prepared by Randomaize.com and will be placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study will be explained to the person who meets the inclusions criteria, and the person will sign the informed consent form and will take an envelope and then will open to enter the intervention or control group based on the contents of the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, physicians (rheumatologist and radiation oncologist), and outcome assessor will be blinded regarding the group of patients. Closed envelope method will be used for blinding.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.MEDSAB.REC.1399.121
2
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2021-01-23, 1399/11/04
Ethics committee reference number
IR.MUBABOL.REC.1399.453
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
Severity of pain
Timepoint
Before the intervention, at the completion of the intervention, and one, three, and six months after intervention
Method of measurement
Visual analog scale
2
Description
Performance status
Timepoint
Before the intervention, at the completion of the intervention, and one, three, and six months after intervention
Method of measurement
von Pannewitz score
3
Description
Quality of life
Timepoint
Before the intervention, at the completion of the intervention, and one, three, and six months after intervention
Method of measurement
The 36-Item Short Form Health Survey questionnaire
Secondary outcomes
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Intervention groups
1
Description
Intervention group: In the radiotherapy group, patients will receive radiotherapy with a daily dose of 0.5 gray for 6 days, every other day.
Category
Treatment - Devices
2
Description
Control group: In the placebo group, patients will receive radiotherapy with a daily dose of 0 gray for 6 days, every other day.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Educational and Medical Center
Full name of responsible person
Seyed Alireza Javadinia
Street address
Vasei hospital , Shohadaye Hasteii Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
javadinia.alireza@gmail.com
Web page address
https://medsab.ac.ir/index.aspx?pageid=339&p=1
2
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Danial Fazilat-Panah
Street address
Shariati Ave.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3527 1790
Fax
+98 11 3528 9262
Email
drfazilatpanah@gmail.com
Web page address
http://rajaee.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Tohid Shahr BLV.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8319
Email
GhoratF@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganz Afrroz Ave.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Deidentified demographic information and data about the primary outcome measures will be shared.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Data will be only available for people working in academic institutions.
Under which criteria data/document could be used
Data will only be shared for research oriented conditions.
From where data/document is obtainable
In order to access the data, applicant should send an request email to Dr Seyed Alireza Javadinia at javadinia.alireza@gmail.com.
What processes are involved for a request to access data/document
After receiving an official request, communication will be performed by Ethics Committee of Sabzevar University of medical Sciences for further authorizations.