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IRCT20100127003217N14 IRCT 2022-11-09 Tabriz University of Medical Sciences Comparison of the effects of local ozone and corticosteroid injection in the treatment of adhesive capsulitis of the shoulder Comparison of local ozone injection vs corticosteroid injection in the treatment of shoulder adhesive capsulitis 2022-11-22 anticipated 40 Complete https://irct.ir/trial/66661 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A box containing 40 sealed envelopes is selected and group A paper is placed inside 20 envelopes and group B paper is placed inside 20 envelopes. This box is placed in front of patients and one envelope is chosen by each patient. In this way, the patients are completely unaware of the selected group and are randomly assigned to group A (Ozone injection) or group B (Cortone injection), Blinding description: Away from the patient's eyes, the desired injectable substance will be prepared in the syringe and the syringes will be covered with an aluminum sheet so that the person does not know the type of injected substance.Due to the different nature of ozone (gas), during the injection, there is a possibility that the injecting person will understand the nature of this injected substance.The statistical analysis person is also kept blind. 3 Adhesive capsulitis of the shoulder. Intervention 1: Intervention group:The first intervention group: Ozone with a concentration of 15 micro-gram in the shoulder joint area, blindly and with a posterior approach. Intervention 2: Intervention group: The second intervention group: Methylprednisolone acetate (40 mg) in the shoulder joint area with a posterior approach and blindly. 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 Fariba Eslamiyan
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3967 eslamiyanf@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Fariba Eslamiyan
Imam Reza Hospital, The end of Golgasht St, Daneshgah St
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3967 Eslamiyanf@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age more than 20 years Diagnosis of shoulder adhesive capsulitis based on specialized shoulder tests such as active and passive ROM Pain intensity based on VAS criteria is greater than or equal to 4 Consent to enter the study 20 years no limit Both Drug addiction History of coagulation disorders, rheumatological diseases, History of intra-articular injection during the previous three months Use of anticoagulants Hypersensitivity reaction to lidocaine Neck radiculopathy Cellulitis and skin infection at the site of intra-articular injection Contraindications for ozone therapy include known cases of G6PD deficiency, uncontrolled hyperthyroidism, pregnancy, and leukemia M75.0 Adhesive capsulitis of shoulder Treatment - Other Treatment - Other Intervention group:The first intervention group: Ozone with a concentration of 15 micro-gram in the shoulder joint area, blindly and with a posterior approach Intervention group: The second intervention group: Methylprednisolone acetate (40 mg) in the shoulder joint area with a posterior approach and blindly Pain intensity. Timepoint: Before the intervention, 2 weeks and 8 weeks after the treatment. Method of measurement: Visual analogue scale (VAS). Shoulder joint range of motion. Timepoint: Before the intervention, 2 weeks and 8 weeks after the treatment. Method of measurement: Goniometry. Functional disability of shoulder-related activities. Timepoint: Before the intervention, 2 weeks and 8 weeks after the treatment. Method of measurement: Shoulder Pain and Disability Index (SPADI). Tabriz University of Medical Sciences Approved 2022-10-03 Ethics Committee of Tabriz University of Medical Sciences Daneshgah Ave, executive field of Tabriz University of Medical Sciences, Vice-Chancellor for research of Tabriz University of Medical Sciences, University Ethics Committee Tabriz East Azarbaijan Iran (Islamic Republic of)