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IRCT20130523013442N28 IRCT 2019-08-01 Shahid Beheshti University of Medical Sciences Evaluation of hyaluronic acid effectiveness in treatment of frozen shoulder Evaluation of efficacy and safety of US guided Intra-articular injections of Hyaluronic acid versus corticosteroid in patients with frozen shoulder (Adhesive Capsulitis) 2019-07-22 anticipated 40 Complete https://irct.ir/trial/39860 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, subjects will be randomly allocated by individual simple randomization method to 2 intervention groups of 20, using computer random number generator, crating numbers between 0&1, and numbers smaller than 0.500 were allocated to group T1 (steroid) and numbers greater than 0.500 were allocated to group T2 (hyaluronic acid), Blinding description: Subjects will be blinded by using pre-filled syringes for injections, the interventionist is not in the research team. The researcher and the statistician are also blind to treatment groups. N/A Frozen Shoulder. Intervention 1: Intervention group: US guided intra-articular injection of 1 cc hyaluronic acid with 1 cc lidocaine 2%. Intervention 2: Control group: US-guided intra-articular injection of 1 cc triamcinolone 40 mg with 1 cc 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 There is no further information.
public Khadijeh Samadnejad
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2236 3244 kh.samadnejad@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Ahmad Raeissadat
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2236 3244 a_raeissadat@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients with frozen shoulder 18 years 65 years Both Recent fracture in the affected shoulder History of inflammation and joint infections Any bone lesion in the affected shoulder Physical therapy or any intra-articular injections in the glenohumeral joint during the past three months History of surgery on the affected shoulder History of allergy to steroids and hyaluronic acid Recurrence of the disease in the affected shoulder M75.0 Adhesive capsulitis of shoulder Treatment - Drugs Treatment - Drugs Intervention group: US guided intra-articular injection of 1 cc hyaluronic acid with 1 cc lidocaine 2% Control group: US-guided intra-articular injection of 1 cc triamcinolone 40 mg with 1 cc lidocaine 2% Pain. Timepoint: Before intervention, 1 week and 4 weeks after injection. Method of measurement: Visual Analogue Scale. Active and passive range of motion. Timepoint: Before intervention, 1 week and 4 weeks after injection. Method of measurement: goniometer. Shoulder function. Timepoint: Before intervention, 1 week and 4 weeks after injection. Method of measurement: Oxford, Shoulder Pain and Disability Index. Shahid Beheshti University of Medical Sciences Approved 2019-05-21 Ethic Committe of Shahid Beheshti University of Medical Sciences No. 1983969411, Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)