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IRCT20170608034390N5 IRCT 2020-01-16 Shahid Beheshti University of Medical Sciences Comparison between effectiveness of two different molecular weights of hyaluronic acid on shoulder tendinopathy. A Comparison between subacromial space injections of Low Molecular Weight Hyaluronic Acid (Hyalgan® MW= 500-700 KD) and High Molecular Weight Hyaluronic Acid (Synogel® MW>2000 KD) in Rotator Cuff Tendinopathy. 2018-06-22 anticipated 56 Complete https://irct.ir/trial/33043 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided with the same ratio in two groups and a web base software (www.sealedenvelope.com) was applied and 14 blocks of 4 subjects were created for block randomization, 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 Rotator cuff tendinopathy. Intervention 1: Intervention group: High MW of Hyaluronic acid (Synogel® MW>2000 KD) injection in subacromial space of shoulder with Codman's (pendulum) Exercises. Intervention 2: Intervention group: Low MW of Hyaluronic acid (Hyalgan® MW= 500-700 KD) injection in Subacromial space of shoulder with Codman's (pendulum) Exercises. Yes - There is a plan to make this available What will be shared: potentially the whole data is published after participants become unidentified. When: The access Starts in 6 months period after publishing of the results. 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 Sciences. How to obtain: It well be available with sending request. Comments:
public Hadi Esmaily
Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 Esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hadi Esmaily
Shahid Beheshti Pharmaceutical Faculty, Vali Asr 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) Tendinopathy of Rotator Cuff َAdults (16-70 years) At least 6 weeks from the onset of pain 16 years 70 years Both Pregnant or lactating Women Active systemic rheumatologic disorders Coagulopathies or on anticoagulant medication Diabetes mellitus Active septic disorders or history of cancers or tumors around the site of shoulder joint Use of systemic corticosteroid drugs recently in one month M75.102 Unsp rotatr-cuff tear/ruptr of left shoulder, not trauma. Treatment - Drugs Treatment - Drugs Intervention group: High MW of Hyaluronic acid (Synogel® MW>2000 KD) injection in subacromial space of shoulder with Codman's (pendulum) Exercises Intervention group: Low MW of Hyaluronic acid (Hyalgan® MW= 500-700 KD) injection in Subacromial space of shoulder with Codman's (pendulum) Exercises Pain intensity based on visual analogue scale. Timepoint: Measuring the severity of pain at the beginning of the study (before the intervention), one week, one month and three months after the injection. Method of measurement: Visual Analogue Scale (VAS). Range of Motion (ROM). Timepoint: Measuring the range of motion at the beginning of the study (before the intervention), one week, one month and three months after the injection. Method of measurement: Goniometer. Adverse events (e.g., Inflammation in the injection site). Timepoint: Inflammation in the injection site at the first week of study after the injection. Method of measurement: Hyperemia, warmth, pain, tendonitis, tenderness. The disabilities of the arm, shoulder and hand. Timepoint: Measuring the disabilities of the arm, shoulder and hand at the beginning of the study (before the intervention), one week, one month and three months after the injection. Method of measurement: The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. Quality of life. Timepoint: Measuring the Quality of life at the beginning of the study (before the intervention), one week, one month and three months after the injection. Method of measurement: QOL-BREF Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2018-05-28 Research Ethics Committee School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Central department of ministry of health and medical education, Simaye Iran st, Shahrak Ghods Tehran Tehran Iran (Islamic Republic of)