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IRCT20180423039388N1 IRCT 2024-04-21 deputy of research - Iran university of medical science Efficacy of Cortone injection on frozen shoulder Comparison of therapeutic outcomes of intra-articular injection of Betamethasone and Methylprednisolone in frozen shoulder 2024-01-21 anticipated 72 Complete https://irct.ir/trial/74640 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To perform randomization using a random numbers table , first, the researcher will determine the direction of reading the numbers in the table in advance (for example, up, down, left, or right), then use the default in considering the numbers for different groups. (for example, even numbers for intervention A and odd numbers for intervention B), the researcher will put his hand on one of the numbers, move in one of the predetermined directions, record the numbers, and assign them to different groups. We will continue this work until the number of samples is complete, Blinding description: In this study, the double-blind (patients and researcher) will be used. That is, the outcome assessors and the participants will be unaware of the type of injected drug. Since the type of intervention is nameless and will be specified with special codes that cannot be distinguished, the patient and the outcome assessor can not be able to distinguish the type of intervention. On the other hand, the injection methods in the two methods are completely similar ( such as similar equipment) and will be carried out in completely identical conditions so that patients cannot differentiate interventions. 3 frozen shoulder (adhesive capsulitis). Intervention 1: 1st Intervention group: single dose of intra-articular injection of 1cc(40mg)Methylprednisolone mixed with 3cc lidocaine 2%. Intervention 2: 2nd Intervention group: single dose of intra-articular injection of 1cc(4mg))Betamethasone mixed with 3cc lidocaine 2%. 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 Amir Sobhani Eraghi
Rasool Akram hospital , mansoori street , Sattarkhan Blvd
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 1111 sobhani.a@iums.ac.ir Iran University of Medical Sciences scientific Amir Sobhani Eraghi
Rasool Akram hospital , mansoori street , Sattarkhan Blvd
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 1111 Sobhani.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) patients with ages between 18 and 80 active and passive restriction of shoulder range of motion (forward flexion less than 100 degrees, external rotation less than 30 degrees, internal rotation less than L1 vertebra, Stage 2 or 3 adhesive capsulitis according to the classification of Hannafin and Chiaia complaint of pain for 1month at least and of ROM restriction for 3 months at least written consent of participation in study 18 years 80 years Both shoulder corticosteroids injection in last 6 months chronic long-term use of oral corticosteroids or in last 2 weeks history of shoulder surgery, shoulder fracture, shoulder dislocation in last 3 months shoulder septic or inflammatory arthritis or any evidence in favor of shoulder cellulitis uncontrolled Diabetes (HbA1C more than 7%, injection day BS more than 300) cuff full thickness tear or cuff partial thickness tear more than 50% in shoulder MRI Calcium deposition or Glenohumeral Osteoarthritis in shoulder AP and Axillary Xray neuromuscular diseases, systemic skeletal diseases, skeletal or soft tissue cancers of shoulder or organs around the shoulder use of Warfarin, Rivaroxaban, Apixaban, or any evidence in favor of bleeding susceptibility (INR>2, aptt>80 sec, platelet< 50000) M75.0 Adhesive capsulitis of shoulder Treatment - Drugs Treatment - Drugs 1st Intervention group: single dose of intra-articular injection of 1cc(40mg)Methylprednisolone mixed with 3cc lidocaine 2% 2nd Intervention group: single dose of intra-articular injection of 1cc(4mg))Betamethasone mixed with 3cc lidocaine 2% Pain. Timepoint: before injection and 1, 3 , 6 months after injection. Method of measurement: visual analog scale. Shoulder range of motion. Timepoint: before injection and 1, 3 , 6 months after injection. Method of measurement: exam with goniometer. Shoulder and pain disability. Timepoint: before injection and 6 months after injection. Method of measurement: SPADI questionnaire(Shoulder Pain And Disability Index). deputy of research - Iran university of medical science Approved 2023-03-11 Ethics committee of Iran University of Medical Sciences Rasool Akram hospital,Mansoori street , Sattarkhan Blvd Tehran Tehran Iran (Islamic Republic of)