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IRCT20170608034390N7 IRCT 2021-01-18 Shahid Beheshti University of Medical Sciences Comparison between effectiveness of two different molecular weights of hyaluronic acid and physiotherapy on shoulder tendinopathy. Evaluating the effect of subacromial space injections of Low Molecular Weight Hyaluronic Acid or High Molecular Weight Hyaluronic Acid in comparison with Physiotherapy in Shoulder Tendinopathy. A Three Arm Randomized Controlled Trial. 2018-10-08 anticipated 84 Complete https://irct.ir/trial/53352 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided with the same ratio in three groups and a web base software (www.sealedenvelope.com) was applied and 14 blocks of 6 subjects were created for block randomization, Blinding description: Researchers including the physician who assess the eligibility of patients, the physician who monitors response to interventions, the statistical analyst, and the controller of study quality, were all blinded, but due to the different nature of interventions, it was not possible to blind the administrants, in this regards a sealed envelope containing the patient's treatment code was sent to injector and physiotherapist who only administered the interventions based on the codes, and they were excluded from the patient eligibility, treatment and outcome assessments. Since one of the interventions was physiotherapy, it was not possible to blind patients. 3 shoulder tendinophaty(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. Intervention 3: Intervention group: For the Physiotherapy group, it prescribed 3 sessions of treatment per week for 4 weeks, totaling 10 sessions, 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 will be available with sending a request by email to corresponding author (Esmaily_hadi@sbmu.ac.ir). 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 shoulder 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 M75.80 Other shoulder lesions, unspecified shoulder Treatment - Drugs Treatment - Drugs Rehabilitation 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 Intervention group: For the Physiotherapy group, it prescribed 3 sessions of treatment per week for 4 weeks, totaling 10 sessions, 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. Pain of the injection site. Timepoint: Check for the pain at the injection site, one day after injection. Method of measurement: Visual Analogue Scale (VAS). 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 2018-10-08 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)