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IRCT2016122424572N4 IRCT 2017-01-27 Iran University of Medical Sciences The comparison of effects of ozone and corticosteroids injection in treatment of shoulder inflammatory diseases The comparison of single session ultrasound-guided ozone and corticosteroid injection in shoulder tendinopathy 2016-10-16 anticipated 30 Complete https://irct.ir/trial/20695 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization: block, Unit of randomization: individual, Tools used in randomization: table of random numbers, Blinding description: This is a double-blind study in which patients and outcomes analyzer are blinded. In order to blind the patient, it is said that both materials are effective for treatment, but the type of substance is not mentioned for patients when its injected. In order to blind the analyzer, the persons responsible for injection and data collection are different from the outcome assessors. N/A Shoulder tendinopathy. Intervention 1: Control group: Ultrasound-guided injection of corticosteroid in the subacromial space with lateral approach. Intervention 2: Intervention group: ULtrasound-guided injection of ozone in the subacromial space with lateral approach. Yes - There is a plan to make this available What will be shared: All the patient's data can be shared with privacy in regard to patients name When: Start accessing 6 months after publishing the results. To whom: For scholars working in academic centers. Conditions: It can be analyzed and printed by other people by mentioning the source. Where to obtain: Dr. Mohammad Sadegh Khabbaz, 00989112840455, m.sadegh.khabbaz@gmail.com. How to obtain: Upon authentication, data is provided to the individual. Comments:
public Mohammad Sadegh Khabbaz
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square.
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1201 m.sadegh.khabbaz@gmail.com 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) Age between 20 and 80 years; Shoulder tendinopathy as positive result of specific test like Neer & Hawkins test; Visual Analogue Scale (VAS) > 4; The willingness of patients to participate in research projects; The absence history of rotator cuff tear, diabetes, coagulation disorders, fractures, rheumatologic diseases, tumors, and infections; Not having shoulder injection in last 3 months; The absence of intraarticular injection contraindications like anticoagulant medications consumption; The absence of corticosteroid and lidocaine injection contraindications such as allergy reaction to these medications and skin infection at the injection site; The absence of ozone injection contraindications such as G6PDD, uncontrolled hyperthyroid, the first 3 months of pregnancy, leukemia. 20 years 80 years Both The willingness of patients to exit from the study at any stage of the project; Noncoming patient for follow-up and evaluation during the follow-up study; Daily use of any type of pain medication by patients for the duration of the study. M75.4 Impingement syndrome of shoulder Treatment - Other Treatment - Other Control group: Ultrasound-guided injection of corticosteroid in the subacromial space with lateral approach Intervention group: ULtrasound-guided injection of ozone in the subacromial space with lateral approach The severity of symptoms. Timepoint: Zero, two weeks and two months after. Method of measurement: Visual Analog Scale (VAS). Shoulder Pain and Disability Index. Timepoint: Zero, two weeks and two months after. Method of measurement: SPADI questionnaire. The severity of symptoms and functional limitations. Timepoint: Zero, two weeks and two months after. Method of measurement: Constant score questionnaire. Side effects. Timepoint: Two weeks and two months after. Method of measurement: Physical examination. Iran University of Medical Sciences Approved 2016-10-16 Ethics Committee of Iran Universiy of Medical Science Medical faculty, Iran University of Medical Sience, Hemmat High way Tehran Tehran Iran (Islamic Republic of)