Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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In the intervention group, patients will receive radiotherapy every other day at the daily dose of 0.5 gray for 6 sessions.
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Main outcome variables
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Severity of pain, performance score, and quality of life of patients will be assessed before and after the intervention.
General information
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Reason for update
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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.
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Acronym
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RTOA
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IRCT registration information
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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
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Registration date
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2020-12-01, 1399/09/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-03-21, 1400/01/01
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Expected recruitment end date
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2022-03-21, 1401/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of low dose radiotherapy on pain relief, performance score, and quality of life in patients with knee joints degenerative disorders
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Public title
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Effectiveness of radiotherapy on pain, performance score, and quality of life in patients with knee joints osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
knee joints osteoarthritis
Age equal and more than 50 years
Exclusion criteria:
Previous history of radiotherapy of affected joint
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Age
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From 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
160
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-22, 1399/09/02
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Ethics committee reference number
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IR.MEDSAB.REC.1399.121
2
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Ethics committee
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Approval date
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2021-01-23, 1399/11/04
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Ethics committee reference number
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IR.MUBABOL.REC.1399.453
Health conditions studied
1
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Description of health condition studied
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Osteoarthritis of knee
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Severity of pain
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Timepoint
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Before the intervention, at the completion of the intervention, and one, three, and six months after intervention
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Method of measurement
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Visual analog scale
2
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Description
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Performance status
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Timepoint
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Before the intervention, at the completion of the intervention, and one, three, and six months after intervention
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Method of measurement
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von Pannewitz score
3
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Description
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Quality of life
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Timepoint
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Before the intervention, at the completion of the intervention, and one, three, and six months after intervention
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Method of measurement
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The 36-Item Short Form Health Survey questionnaire
Intervention groups
1
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Description
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Intervention group: In the radiotherapy group, patients will receive radiotherapy with a daily dose of 0.5 gray for 6 days, every other day.
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Category
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Treatment - Devices
2
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Description
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Control group: In the placebo group, patients will receive radiotherapy with a daily dose of 0 gray for 6 days, every other day.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sabzevar University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Deidentified demographic information and data about the primary outcome measures will be shared.
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When the data will become available and for how long
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Starting 6 months after publication
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To whom data/document is available
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Data will be only available for people working in academic institutions.
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Under which criteria data/document could be used
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Data will only be shared for research oriented conditions.
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From where data/document is obtainable
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In order to access the data, applicant should send an request email to Dr Seyed Alireza Javadinia at javadinia.alireza@gmail.com.
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What processes are involved for a request to access data/document
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After receiving an official request, communication will be performed by Ethics Committee of Sabzevar University of medical Sciences for further authorizations.
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Comments
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