Comparison of the Effects of PRP and Corticosteroid on the Treatment of Knee Osteoarthritis
Design
A total of 44 knees from 22 patients with mild to moderate knee osteoarthritis will be randomly allocated to one of two intra-articular injection groups: corticosteroid or PRP. At the end of the second, fourth, and sixth months after treatment, the patients will be evaluated for osteoarthritis-related outcomes and knee injuries using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.
Settings and conduct
Therefore, the patient and the outcome assessor will remain unaware of the type of injection administered until the patients’ pain scores have been assessed and the data have been analyzed. Finally, to ensure blinding of the individual responsible for data analysis, the study arms will be entered into the software using the codes A and B, and the coded data will be provided to the analyst for statistical analysis.
Participants/Inclusion and exclusion criteria
Patients over 50 years of age with mild to moderate knee osteoarthritis.
Intervention groups
One group receiving intra-articular corticosteroid injection and one group receiving intra-articular PRP injection.
Main outcome variables
Assessment and comparison of pain, activities of daily living, sports and recreational activities, quality of life, joint stiffness, and knee discomfort between the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260924071177N1
Registration date:2026-09-28, 1405/07/06
Registration timing:prospective
Last update:2026-09-28, 1405/07/06
Update count:0
Registration date
2026-09-28, 1405/07/06
Registrant information
Name
Behzad Xeyati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3264 0020
Email address
bahoooz.649@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-11-22, 1405/09/01
Expected recruitment end date
2027-11-22, 1406/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of corticosteroids and PRP on the treatment of mild to moderated knee osteoarthritis: A duble blinded randomized clinical trial
Public title
Compairing the effects of corticosteroids and PRP on treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 50 years
Morning stiffness lasting less than 30 minutes
Crepitus during active knee movement
Bony tenderness
Bony enlargement
Absence of evidence of septic arthritis of the knee
Exclusion criteria:
History of rheumatoid arthritis
Evidence of septic arthritis
History of intra-articular injection within the previous 6 months
Any hematological disorder, including coagulopathy
Injection phobia
History of severe knee trauma
Grade 3 osteoarthritis
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
22
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient, one knee will receive PRP injection, while the contralateral knee will receive corticosteroid injection.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be randomly allocated to the intervention groups using a permuted block randomization method with a block size of 4. Accordingly, four slips of paper of equal size and color will be prepared, with the letter A written on two of them and the letter B written on the other two.
This method is similar to sampling without replacement. Upon enrollment of each eligible patient, one slip will be randomly selected. If the selected slip bears the letter A, the patient will be assigned to the PRP injection group, whereas if it bears the letter B, the patient will be assigned to the corticosteroid injection group. After a slip is selected, it will be removed from the pool, leaving three slips to randomly determine the treatment allocation of the next three eligible patients.
At the end of each block, two patients will have been allocated to the PRP group and two patients to the corticosteroid group, thereby ensuring an equal sample size in the two treatment groups. This procedure will continue until the required sample size is reached, with patients being allocated equally to the two treatment groups under investigation.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted using a double-blind design. Accordingly, the individual responsible for assessing the outcomes of osteoarthritis and knee injuries at the second and sixth months after treatment, as well as the patient and, ultimately, the individual responsible for data analysis, will be blinded to the type of injection administered to each knee. Specifically, they will be unaware of which knee received PRP and which knee received corticosteroid.
To blind the patients and the outcome assessor, PRP and corticosteroid will be drawn into identical syringes by a nurse and labeled with codes before being provided to the surgeon for injection. Therefore, the patient and the outcome assessor will remain unaware of the type of injection administered until the pain scores and other outcome measures have been assessed.
Finally, to blind the data analyst, the treatment arms will be entered into the software using codes A and B, and the coded dataset will be provided to the analyst for statistical analysis. Thus, the data analyst will remain unaware of the actual treatment allocation during the analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Pain score in patients with osteoarthritis, assessed using the KOOS questionnaire.
Timepoint
The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection.
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
2
Description
Activities of Daily Living (ADL) Score Assessed Using the KOOS Questionnaire
Timepoint
The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection.
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
3
Description
Sport and Recreation Function Score in Patients with Osteoarthritis Assessed Using the KOOS Questionnaire
Timepoint
The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection.
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
4
Description
Knee-Related Quality of Life (QoL) Score Assessed Using the KOOS Questionnaire
Timepoint
The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection.
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
5
Description
Knee Stiffness Score Assessed Using the KOOS Questionnaire
Timepoint
The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection.
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
6
Description
Knee Symptoms Score in Patients with Osteoarthritis Assessed Using the KOOS Questionnaire
Timepoint
The effects of intra-articular corticosteroid and PRP injections at baseline and at the end of the second, fourth, and sixth months after injection.
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention Group: Participants in the first intervention group will receive a single intra-articular injection of 8 mg dexamethasone (corticosteroid) under sterile conditions.
Category
Treatment - Drugs
2
Description
Second Intervention Group: Participants in the second intervention group will receive a single intra-articular injection of platelet-rich plasma (PRP) under sterile conditions. Briefly, 18 mL of peripheral venous blood will be collected from each participant and transferred into two sterile vacuum tubes, each containing 1 mL of anticoagulant. The blood samples will initially be centrifuged at 2,500 rpm for 10 minutes. Subsequently, the samples will undergo a second centrifugation at 1,500 rpm for 10 minutes. Following the second centrifugation step, approximately 3 mL of pure platelet-rich plasma (PRP) will be obtained and administered as a single intra-articular injection under sterile conditions.
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no plan to share or disseminate the de-identified individual participant data after completion of this study. The data will be used solely for research purposes, statistical analysis, and reporting of the study results. The confidentiality of participants’ information will be maintained in accordance with ethical principles.