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IRCT20170608034390N4 IRCT 2020-01-01 Shahid Beheshti University of Medical Sciences Comparing the Add on Effectiveness of Intra-Articular Injections of High Molecular Weight Hyaluronic Acid (Viscor®>2000 KD) with Low Molecular Weight Hyaluronic Acid (Hyalgan® MW= 500-800 KD) and Lidocaine In Frozen Shoulder Conventional Physical Therapy. Evaluating the Efficacy and Safety of adding Intra- Articular High Molecular Weight Hyaluronic Acid (Viscor® MW>2000 KD) Injections in Comparison of Low Molecular Weight Hyaluronic Acid (Hyalgan® MW= 500-800 KD) and lidocaine In Idiopathic Adhesive Capsulitis 2018-11-22 anticipated 50 Complete https://irct.ir/trial/37113 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We used block randomization method, Blinding description: All Participants, Investigators, Outcome assessors, Data analyst and quality controller are blinded. Sequentially numbered opaque sealed envelopes containing treatment allocations were prepared and were opened in sequence by an independent administrator who was not involved in eligibility, treatment, or outcome measurement. 3 Idiopathic Adhesive Capsulitis (Frozen Shoulder). Intervention 1: Intervention group: One arm revived intra-articular injection of High Molecular Weight hyaluronic acid (Viscor® >2000 KD) in shoulder joint adding to the conventional physical therapy. Intervention 2: Intervention group: Second arm revived intra articular injection of Low Molecular Weight hyaluronic acid (Hyalgan® 500-800 KD) in shoulder joint adding to the conventional physical therapy. Yes - There is a plan to make this available What will be shared: the whole potential data is unpublished after being unidentifiable. When: start the access period 6 month after pricing the result To whom: researchers working in academic and industrial institutions. Conditions: it can be used to carry out research work. Where to obtain: Dr Hadi Esmaily, faculty of pharmacy, shahid beheshti university of medical science How to obtain: sending request is available. Comments:
public Hadi Esmaily
Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe
Tehran Iran (Islamic Republic of) 1991953381 +98 211579064 Esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hadi Esmaily
Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Adults (>18 years) Less than 65 years old It takes less than three month from the onset of the disorder 18 years 65 years Both History of Traumatic Injury to the shoulder Active Tendonitis History of rotator cuff tear History of NSAIDs use during the last week History of systemic corticosteroid use during the last 1 month M75.00 Adhesive capsulitis of unspecified shoulder Treatment - Drugs Treatment - Drugs Intervention group: One arm revived intra-articular injection of High Molecular Weight hyaluronic acid (Viscor® >2000 KD) in shoulder joint adding to the conventional physical therapy. Intervention group: Second arm revived intra articular injection of Low Molecular Weight hyaluronic acid (Hyalgan® 500-800 KD) in shoulder joint adding to the conventional physical therapy. Pain. Timepoint: At baseline, 4, 12 and 24 weeks after injection. Method of measurement: Visual Analog Scale. Range of Motion. Timepoint: At baseline, 4 and 12 weeks after injection. Method of measurement: Goniometry. Inflammation Signs and Symptoms. Timepoint: at baseline of injection. Method of measurement: Hyperemia, Warmly, Pain, Tendonitis, Tenderness. Oxford Shoulder Score. Timepoint: At baseline, 4 and 12 weeks after injection. Method of measurement: Oxford Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2018-11-13 National Ethics Committee for Biomedical Research Central Department of Ministerial of Health and Medical Education, Sima Iran St, between South Falamak and Zarafshan St, Shark Gharb Tehran Tehran Iran (Islamic Republic of)