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IRCT20221104056393N3 IRCT 2024-01-11 Shahid Beheshti University of Medical Sciences Therapeutic effect of Adipose-derived Stromal Vascular Fraction on Lateral Epicondylitis Therapeutic effect of Adipose-derived Stromal Vascular Fraction on Lateral Epicondylitis (Tennis Elbow) disease, A randomized controlled trial 2023-12-01 anticipated 54 Complete https://irct.ir/trial/73774 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this randomized clinical trial study, randomization is carried out by the 4-way box method in which 2 chances are considered for each group, and 2 out of 4 people are randomly entered into each group by the order of visiting the clinic, Blinding description: In this study, due to the need for liposuction in the Stromal Vascular Fraction (SVF) group, it is not possible to blind the patients to the type of treatment, but the person who collects the patient's information and also the person who analyzes the final data will be blinded to the group allocation. 3 Lateral epicondylitis. Intervention 1: About 100 mL of adipose tissue is taken under sterile condition through liposuction of the abdomen. The obtained fat will be emulsified by passing through 2.4 mm, 1.2 mm filters and finally a 400 and 600 micrometer filter (25-30 passes). In order to separate free fatty acids, these nanofats are centrifuged (for 2 minutes at 1200 rpm) and the separated fatty acids will be discarded. The number of cells in the remaining substance will be counted under the microscope. The obtained nanofat will be used for injection. The injection will be done for all patients in the external epicondyle area. Intervention 2: Control group: Patients in the control group will receive corticosteroids and normal saline. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared after making the individuals undetectable When: Access will be granted 6 months after the results of the study are published. To whom: Researchers and medical specialist Conditions: based on the Ministry of Health and Medical Education criteria for clinical trials Where to obtain: Dr. Reza Robati, Dermatology research center, Tajrish, Tehran How to obtain: The data that support the findings of this study will be available on request from the corresponding author. The data will not be publicly available due to privacy and ethical considerations. Comments:
public Reza Robati
Shohada Tajrish Educational Medical Center, Shahrdari St, Tajrish Sq
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1507 rezarobati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Reza Robati
Shohada Tajrish Educational Medical Center, Shahrdari St, Tajrish Sq
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1507 rezarobati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) At least 4 months passed since onset of pain not responding to conservative therapy for 3 months A history of one unsuccessful corticosteroid or PRP injection in the past 3 months (at least 2 months have passed since the injection) The patient has the ability to understand the explanations and registers his oral and written desire in the informed consent form. no limit no limit Both Any history of an injection in the elbow during the past 2 months History of cardiovascular disease such as previous myocardial infarction or heart failure Coagulopathies such as disrupted PT, PTT, INR Pregnancy or breastfeeding Drug users or alcoholics Elbow pain due to other musculoskeletal diseases such as rheumatoid arthritis, fibromyalgia, etc. M77.10 Lateral epicondylitis, unspecified elbow Treatment - Other Treatment - Other About 100 mL of adipose tissue is taken under sterile condition through liposuction of the abdomen. The obtained fat will be emulsified by passing through 2.4 mm, 1.2 mm filters and finally a 400 and 600 micrometer filter (25-30 passes). In order to separate free fatty acids, these nanofats are centrifuged (for 2 minutes at 1200 rpm) and the separated fatty acids will be discarded. The number of cells in the remaining substance will be counted under the microscope. The obtained nanofat will be used for injection. The injection will be done for all patients in the external epicondyle area. Control group: Patients in the control group will receive corticosteroids and normal saline. Elbow function. Timepoint: Before the intervention, 1, 3, 6 months after the intervention. Method of measurement: QuickDASH and MEPI questionnaire. The patient's pain level. Timepoint: Before the intervention, 1, 3, 6 months after the intervention. Method of measurement: VAS questionnaire. Radiological evaluation of the lesion in the form of CEO tendon lesion measurement. Timepoint: Before the intervention, 6 months after the intervention. Method of measurement: MRI examination by a radiologist. Shahid Beheshti University of Medical Sciences Approved 2023-11-01 Research Ethics Committees of Shahid Beheshti University of Medical Sciences Azar dead end alley, Sharifi Manesh street., Pole Roomi, Tajrish Tehran Tehran Iran (Islamic Republic of)