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IRCT20151017024572N16 IRCT 2018-06-24 Tabriz University of Medical Sciences Evaluation of the Effect of Local Injection of Ozone and Corticosteroid and Prolotropics Under Sonography on Treatment of Tennis Elbow Syndrome (Elbow Tennis) Evaluation of the Effect of Local Injection of Ozone and Corticosteroid and Prolotropics Under Sonography on Elbow Syndrome Tennis Players (TB): A Multi-centered Double-Blind Randomized Clinical Trial 2017-08-23 anticipated 75 Complete https://irct.ir/trial/20699 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple random method for randomization will be used and individuals (patients) will form random units. A random sequence will be generated using RAS software. A central randomization method will be used to conceal random allocation. The random sequence will be created by the statistician and will be available to her. The doctor will be connected to the statistician by telephone or text message and will ask him or her about the random allocation of the participant to the specific group, Blinding description: This randomized, double-blind randomized clinical trial is a multi-centered patient with a positive control group and will be performed in four groups of patients with musculoskeletal disorders by four physicians and physicians in four different health centers. All patients will be given enough information about the properties of ozone and corticosteroid injections, possible side effects, method and duration of testing, and the likelihood of having a candidate from one of the two treatments. All patients will be asked to sign a written informed consent form.In order to blind the patient, the doctor will prepare the injection material in the syringe, and will cover the syringes with an aluminum sheet to avoid being aware of the type of injection. It should be noted that dilution of corticosteroid and normal salon will be done to equalize the volume of all three injectable solutions. Patients in each group will be evaluated by a physical medicine and rehabilitation specialist who is not aware of the type of injection, before the injection, one week after the injection and two months after the injection, and the rate of change between the two groups will be compared at different times. It should be noted that in each center all injections are performed by a constant person (a physical medicine and rehabilitation specialist). Using three-flood coded questionnaires, where the first flood represents the group, the second flood indicates the time of the measurement of the outcome and the third flood represents the patient's code, the analyst will also be unaware of the allocation of people to the treatment groups. 3 Tennis player elbow syndrome. Intervention 1: Intervention group (ozone therapy): 2cc ozone 20μg / L, at the joint of the common extensor tendon under ultrasound guidance. Intervention 2: Intervention group (porlotherapy): 2cc dextrose 50%, at the joint of the common extensor tendon under ultrasound guidance. Intervention 3: Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc normal slain, at the joint of the common extensor tendon under ultrasound guidance. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Dr. Arash Babaei
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1229 babaei-ghazani.a@iums.ac.ir Iran University of Medical Sciences scientific Dr. Arash Babaei
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1229 babaei-ghazani.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Anxiety in the outer part of the ear for a month Localized tenderness in the external region of the armpit (at the point of attachment of the extensors of the forearm) Exacerbation of pain during supination on the back of the head while maintaining flexion. Exacerbation of pain during dorsiflexion of the wrist against resistance Exacerbation of pain as well as punching along with the pressure of the hand no limit no limit Both There are symptoms for more than 4 weeks or history of trauma to the elbow - History of connective tissue disease or diffuse pain syndrome (such as fibromyalgia, chronic pain syndrome - Inflammatory arthropathy - Use of previous therapies for external epicondylitis - The possibility of creating heavy work Full Radiolysis Brevis Extension Cardiac Tendon Radiculopathy Full Radiolysis Brevis Extension Cardiac Tendon Aphrodisiac Taking anticoagulants Existing Injection Detection G59 Mononeuropathy in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group (ozone therapy): 2cc ozone 20μg / L, at the joint of the common extensor tendon under ultrasound guidance. Intervention group (porlotherapy): 2cc dextrose 50%, at the joint of the common extensor tendon under ultrasound guidance. Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc normal slain, at the joint of the common extensor tendon under ultrasound guidance. Pain. Timepoint: Before injection, 2 weeks and 8 weeks after injection. Method of measurement: Visual Analog Scale (VAS). Clinical Global Impression. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Clinical Global Impression Questionnaire. Patient Global Impression of Improvement. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Patient Global Impression of Improvement Questionnaire. Tennis Elbow Evaluation. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Patient-rated Tennis Elbow Evaluation (PRTEE) Questionnaire. Extensor tendon thickness. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Sonography. Iran University of Medical Sciences Tabriz University of Medical Sciences Iran University of Medical Sciences Approved 2017-06-22 Iran University of Medical Sciences Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)