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IRCT20210910052428N1 IRCT 2021-10-12 Shiraz University of Medical Sciences "Hydrodilatation in adhesive capsulitis", " Intra-articular corticosteroid in adhesive capsulitis" A Comparative study between intra-articular corticosteroid injection and ultrasound-guided hydrodilatation in patients with shoulder adhesive capsulitis 2021-11-20 anticipated 48 Complete https://irct.ir/trial/58893 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To match patients in the intervention and control groups, patients are randomly assigned to one of two treatment groups. The random allocation method in this study will be the permutation blocks randomization method with 4 samples in each block and a random list of data will be obtained by using Random Allocation software. We will have two lists of 24 patients, including the two intervention and control groups, at random. For concealment, method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by a person unaware of the division of groups, Blinding description: Participants in study Participant: in this study, we does not have the ability to blind the participant because the participant is aware of receiving each intervention. Clinical care giver: we teach the caregiver how to complete the questionnaire. This person is not aware of receiving patient’s intervention. Researcher: this study does not have the ability to blind the researcher due to performing both interventions by himself and being aware of receiving the kind of intervention in each group. The outcome assessor of the complete questionnaires is given to a person who is not aware of the intervention performed and he/she is asked to determine the level of performance in each person according to the questionnaires. Data analyzer: questionnaire are finally given to a person to review the information. This person does not know any of the steps of the work and the way of classification in which the intervention performed. 3 Shoulder adhesive capsulitis. Intervention 1: Intervention group: injection of normal saline 0.9% with 25cc/sec rate in prevention of capsular rupture due to large amount injection, with injection of 3cc lidocaine under sterile circumstance and with usage of 20 cc syringe in a condition that syringe be parallel to ultrasound probe in semi oblique plane from posterior aspect of shoulder will be done. Intervention 2: Control group: injection of 1 cc methylprednisolone 40 mg/ml plus 1cc lidocaine 2% and 3cc normal saline in a situation that patient is in a prone position and under sterile circumstance and with usage of 20 cc syringe in a condition that syringe be parallel to ultrasound probe in semi oblique plane from posterior aspect of shoulder will be done. Yes - There is a plan to make this available What will be shared: All available data can be shared after making people unidentifiable. When: Start access period one year after publishing the results. To whom: Everyone can access to this information. Conditions: If the information in this study helps to improve the science process. Where to obtain: Dr.vahide nadgaran v.nadgaran@gmail.com +989171090973 How to obtain: After sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of three weeks if permitted. Comments:
public Vahide Nadgaran
5/1 Alley, South Eghbal lahoori Ave, Ostad Shahriar Ave, Moddaress Blvd
shiraz Iran (Islamic Republic of) 7157748857 +98 71 3722 2038 v.nadgaran@gmail.com Shiraz University of Medical Sciences scientific Vahide Nadgaran
5/1 Alley, South Eghbal lahoori Ave, Ostad Shahriar Ave, Moddaress Blvd
shiraz Iran (Islamic Republic of) 7157748857 +98 71 3722 2038 v.nadgaran@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Presence of pain and shoulder range of motion limitation more than 30 degree in more than two motion plane Presence of pain and shoulder range of motion limitation more than one month no limit no limit Both Shoulder pain after cerebrovascular attack in paretic side Patients with severe glenohumeral joint osteoarthritis Patients with complete rotator cuff ligaments tear Immune deficiency Fracture in humerus bone or scapula Pregnant women Patients with cancer History of allergy and reaction due in use drugs Shoulder joint rheumatoid arthritis Severe depression Uncontrolled diabetes M75.00 Adhesive capsulitis of unspecified shoulder Treatment - Drugs Treatment - Drugs Intervention group: injection of normal saline 0.9% with 25cc/sec rate in prevention of capsular rupture due to large amount injection, with injection of 3cc lidocaine under sterile circumstance and with usage of 20 cc syringe in a condition that syringe be parallel to ultrasound probe in semi oblique plane from posterior aspect of shoulder will be done. Control group: injection of 1 cc methylprednisolone 40 mg/ml plus 1cc lidocaine 2% and 3cc normal saline in a situation that patient is in a prone position and under sterile circumstance and with usage of 20 cc syringe in a condition that syringe be parallel to ultrasound probe in semi oblique plane from posterior aspect of shoulder will be done. " Score of pain in visual analoge scale questionnaire" , " Shoulder disability score in shoulder pain and disability index questionnaire". Timepoint: " Measurement of shoulder range of motion and pain score at the beginning, 2, 4 and 8 weeks after shoulder injection". Method of measurement: Visual analog scale and shoulder pain and disability index. Shoulder Pain. Timepoint: Before intervention; two weeks, four weeks and eight weeks later. Method of measurement: Visual Analogue Scale; Shoulder Pain And Disability Index. Shoulder range of motion. Timepoint: Before intervention; two weeks, four weeks and eight weeks later. Method of measurement: With usage of goniometer. Shiraz University of Medical Sciences Approved 2021-08-30 Ethics committee of Shiraz University of Medical Sciences No 5/1alley, South eghbale lahoori Ave, Ostad shahriar Ave, Moddaress Blvd Shiraz Fars Iran (Islamic Republic of)