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IRCT20160706028815N6 IRCT 2020-12-01 Sabzevar University of Medical Sciences Effectiveness of radiotherapy on pain, performance score, and quality of life in patients with knee joints osteoarthritis RTOA Effects of low dose radiotherapy on pain relief, performance score, and quality of life in patients with knee joints degenerative disorders 2021-03-21 anticipated 160 Complete https://irct.ir/trial/52655 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Osteoarthritis of knee. Intervention 1: Intervention group: In the radiotherapy group, patients will receive radiotherapy with a daily dose of 0.5 gray for 6 days, every other day. Intervention 2: Control group: In the placebo group, patients will receive radiotherapy with a daily dose of 0 gray for 6 days, every other day. Yes - There is a plan to make this available What will be shared: Deidentified demographic information and data about the primary outcome measures will be shared. When: Starting 6 months after publication To whom: Data will be only available for people working in academic institutions. Conditions: Data will only be shared for research oriented conditions. Where to obtain: In order to access the data, applicant should send an request email to Dr Seyed Alireza Javadinia at javadinia.alireza@gmail.com. How to obtain: After receiving an official request, communication will be performed by Ethics Committee of Sabzevar University of medical Sciences for further authorizations. Comments:
public Seyed Alireza Javadinia
Radiotherapy ward, Vasei Hospital, Shohaeye Hasteii BLV.
Sabzevar Iran (Islamic Republic of) 9617747431 +98 51 4465 1300 javadinia.alireza@gmail.com Sabzevar University of Medical Sciences scientific Seyed Alireza Javadinia
Radiotherapy ward, Vasei Hospital, Shohaeye Hasteii BLV.
Sabzevar Iran (Islamic Republic of) 9617747431 +98 51 4465 1300 javadinia.alireza@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) knee joints osteoarthritis Age equal and more than 50 years 50 years no limit Both Previous history of radiotherapy of affected joint M17 Osteoarthritis of knee Treatment - Devices Treatment - Devices Intervention group: In the radiotherapy group, patients will receive radiotherapy with a daily dose of 0.5 gray for 6 days, every other day. Control group: In the placebo group, patients will receive radiotherapy with a daily dose of 0 gray for 6 days, every other day. 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. 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. 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. Babol University of Medical Sciences Sabzevar University of Medical Sciences Babol University of Medical Sciences Approved 2020-11-22 Ethics committee of Sabzevar University of Medical Sciences Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology Sabzevar Razavi Khorasan Iran (Islamic Republic of) Approved 2021-01-23 Ethics committee of Babol University of Medical Sciences Ganj Afrooz Ave Babol Mazandaran Iran (Islamic Republic of)