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IRCT20130523013442N35 IRCT 2023-11-19 Shahid Beheshti University of Medical Sciences Comparison of the Efficacy of ultrasound guided injection of Corticosteroid, Platelet-rich Plasma(PRP), and Ozone on pain and function of patients with lateral epicondylitis Comparison of the Efficacy of ultrasound guided injection of Corticosteroid, Platelet-rich Plasma(PRP), and Ozone on pain and function of patients with lateral epicondylitis: A multicenter randomized clinical trial 2023-11-01 anticipated 90 Complete https://irct.ir/trial/69688 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: in this clinical trial study, 90 patients with a diagnosis of lateral epicondylitis will be included in the study randomly .For random allocation of individuals in the study groups (intervention or intervention group and comparison or comparison group), the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1: 1 will be used. Random Allocation software 2.0 will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified with two type of cards which are including group a (1st intervention group), b (2nd intervention group) and c (control group) and these cards are placed inside the sealed envelopes in order .In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined. Due to the multicenter nature of this study, the randomization of the study subjects will be performed separately in each center, Blinding description: In this study, all patients, caregivers, responsible for data collection, examiner are all unaware of the intervention performed for included participants. To blind the examiner, the injection syringes will be covered. Patients will be randomly assigned to the intervention groups and will not be aware of the injected substance used. 3 lateral epicondylitis. Intervention 1: Intervention group: 30 patients with lateral epicondylitis who are injected with 10 ml of ozone with a concentration of 15 μg/ml under ultrasound guidance. Intervention 2: Intervention group: 30 patients with lateral epicondylitis who are injected with 3 cc of platelets under ultrasound guidance. with a concentration of 4-6 times that of blood platelets resulting from two rounds of centrifugation (first 12 minutes at 1600 rpm and the next round at 7 minutes at 3500 rpm) containing leukocyte poor plasma without adding activators. Intervention 3: Control group: 30 patients with lateral epicondylitis who are injected with 40 mg of methylprednisolone acetate in a volume of 1 ml under ultrasound guidance. Yes - There is a plan to make this available What will be shared: All the data of people participating in this study can be shared after deidentifying people When: The access period starts one year after the results are published To whom: Data of this study will be available to researchers working in academic and scientific institutions Conditions: If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers. Where to obtain: By sending an email to mahfampourazin@gmail.com How to obtain: Sending an e-mail and explaining the purpose and how to use the data Comments:
public Mahfam pourazin
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 mahfampourazin@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Ahmad Raeissadat
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 a_raeissadat@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with treatment-resistant tennis elbow duration of 3 months or more pain intensity of VAS 5 or more age of 20 to 50 years 20 years 50 years Both Symptoms of an infectious disease or fever in the last few days Thyroid dysfunction or uncontrolled diabetes Rheumatic disease History of hematologic or bone malignancy Elbow joint injury Carpal tunnel syndrome and other peripheral nerve injuries including radial nerve injury Cervical radiculopathy that affects the Mayo questionnaire History of autoimmune disease Platelet disorder Treatment with antiplatelet drugs in the last 10 days Platelets below 150,000 Treatment with non-steroidal anti-inflammatory drugs within 48 hours before injection Steroid use in the past 3 weeks Hemoglobin below 10 History of vasovagal shock Pregnancy or breastfeeding Treatment of lateral epicondylitis with steroids in the last 6 months Lateral epicondylitis surgery Ozone sensitivity G6PD Taking ACE inhibitor M77.1 Lateral epicondylitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: 30 patients with lateral epicondylitis who are injected with 10 ml of ozone with a concentration of 15 μg/ml under ultrasound guidance. Intervention group: 30 patients with lateral epicondylitis who are injected with 3 cc of platelets under ultrasound guidance. with a concentration of 4-6 times that of blood platelets resulting from two rounds of centrifugation (first 12 minutes at 1600 rpm and the next round at 7 minutes at 3500 rpm) containing leukocyte poor plasma without adding activators Control group: 30 patients with lateral epicondylitis who are injected with 40 mg of methylprednisolone acetate in a volume of 1 ml under ultrasound guidance. Pain in lateral epicondyle. Timepoint: At the beginning of the study (before the start of the intervention) and 2 months and 6 months after the intervention. Method of measurement: Visual analogue scale (VAS). Pain pressure thresold. Timepoint: At the beginning of the study (before the start of the intervention) and 2 months and 6 months after the intervention. Method of measurement: Algometer. Patient's performance. Timepoint: At the beginning of the study (before the start of the intervention) and 2 months and 6 months after the intervention. Method of measurement: Mayo questionnaire score. Shahid Beheshti University of Medical Sciences Approved 2023-02-22 Research Ethics Committees of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)