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IRCT20181122041727N1 IRCT 2019-12-02 Iran University of Medical Sciences The effects of corticosteroid injection and radial shock wave in the shoulder inflammatory disease The comparison of single session ultrasound-guided corticosteroid injection and radial shock wave therapy in non-calcified shoulder tendinopathy. 2019-12-11 anticipated 36 Complete https://irct.ir/trial/35482 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization, in which each member of the community has an equal chance of being independent, is chosen. The randomization method will be used with random and binary blocks. Regarding the sample size of 36 people, 9 quadruple blocks will be generated and numbered using the permutations method. Using the random number table, blocks will be placed together to form a patient allocation sequence to treatment groups. Providers will be unaware of the type of treatment that will be received, as well as the random sequences generated in the length of the study will be unpredictable, Blinding description: 1- The outcome assessor, would not be aware of the allocation when assessing the patients in the measuring time points. 2-The data analyzer, would not be aware of the allocation when analyzing. 3 Shoulder tendinopathy. Intervention 1: Control group: 1 cc equal 40 mg triamcinolone(Exir Pharmaceutical Company, made in Iran) with 2 cc of 2% lidocaine(Caspian Tamin Pharmaceutical Company, made in Iran) using 22 gauge needle under ultrasound guidance (lateral approach) will be injected in the subacromial space as conventional treatment. Intervention 2: The intervention group will receive three sessions of radial shock wave in three consecutive weeks with 2000 pulses of energy and 4 Hz frequency. Shock wave device, Storz Medical company, Swiss-made will be used. 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 This will be decided upon completion of the final report.
public Negar Aflakian
Physical medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St, Karim Khane Zand St, Tehran
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8214 1229 aflakian.n@tak.iums.ac.ir Iran University of Medical Sciences scientific Dr. Arash Babaei
Physical medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St, Karim Khane Zand St, Tehran
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8214 1229 babaei-ghazani.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Shoulder tendinopathy as a positive result of specific tests like Neer & Hawkins test. Visual analog scale above 4 (VAS>4). The willingness of the patients to participate in the research projects. Not having shoulder injection in the last 4 months. Age between 18 and 65 years. Not being pregnant or having the decision to become pregnant. The absence of intraarticular injection contraindications such as coagulation disorders or taking anticoagulant medicine. Having pain for more than 3 months. 18 years 65 years Both Having any kind of mental illness. Previous history of rotator cuff tear, diabetes, coagulation disorders, fractures, rheumatologic diseases, tumors, and infection. M75.4 Impingement syndrome of shoulder Treatment - Other Treatment - Other Control group: 1 cc equal 40 mg triamcinolone(Exir Pharmaceutical Company, made in Iran) with 2 cc of 2% lidocaine(Caspian Tamin Pharmaceutical Company, made in Iran) using 22 gauge needle under ultrasound guidance (lateral approach) will be injected in the subacromial space as conventional treatment. The intervention group will receive three sessions of radial shock wave in three consecutive weeks with 2000 pulses of energy and 4 Hz frequency. Shock wave device, Storz Medical company, Swiss-made will be used. The severity of symptoms. Timepoint: Before treatment, two weeks and three months after the end of treatment. Method of measurement: Visual Analog Scale (VAS). The amount of physical performance. Timepoint: Before treatment, two weeks and three months after the end of treatment. Method of measurement: Quick DASH questionnaire ( Quick Disabilities of Arm, Shoulder & Hand ). Iran University of Medical Sciences Approved 2018-09-23 Ethics Committee of Iran Universiy of Medical Science Medical faculty, Iran University of Medical Sience, Hemmat High way Tehran Tehran Iran (Islamic Republic of)