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IRCT20210223050470N1 IRCT 2021-05-22 Esfahan University of Medical Sciences Calcitonin in shoulder adhesive capsulitis Evaluation of Calcitonin effects on shoulder adhesive capsulitis 2021-06-22 anticipated 100 Complete https://irct.ir/trial/54512 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using statistical software, a set of numbers is generated and formed in the form of random permutation blocks with a volume of 4. The two smaller numbers in each block are for patients receiving calcitonin, and the two larger numbers are for patients not receiving calcitonin. Each patient is assigned a number according to the order of enrollment, and depending on whether the number assigned to the patient in the permutation block of 4 is among the large numbers or small numbers, the patient is either in the spray receiving group or the group who do not receive spray, Blinding description: Principal Investigator who initially examines the patients to assess inclusion and exclusion criterion and determines the eligible patients to enter the intervention and visits them in the follow-up process, is unaware of which group the patients are in. Another person divides patients into two groups according to the aforementioned randomization method, the group receiving the spray and the group who do not not receive the spray. The data analyzer is also unaware of which group the patients belonged to. N/A adhesive capsulitis of shoulder. Intervention 1: Intervention group: this group receives nasal calcitonin spray. It should be used with dosage of one puff daily for 8 weeks. Intervention 2: Control group: this group does not receive calcitonin spray. Yes - There is a plan to make this available What will be shared: Data is encrypted in order to make the identities of individuals unidentifiable and confidential When: after To whom: University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers Conditions: ystematic review or meta-analysis by mentioning the document Where to obtain: Dr. mohammad dehghani How to obtain: After submitting the application via academic email, we will provide the information files to the individuals within a maximum of one month. Comments:
public Mohammad Dehghani
No 38, 2nd alley, Mollasadra St.
Esfahan Iran (Islamic Republic of) 8168613441 0098316688644 shakibadehghanii@gmail.com Esfahan University of Medical Sciences scientific Mohammad Dehghani
No 38, 2nd alley, Mollasadra St.
Isfahan Iran (Islamic Republic of) 8168613441 0098316688644 m_dehghani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with adhesive capsulitis (Diagnostic criterion: 1. Shoulder pain and stiffness for at least 4 weeks 2. Severe shoulder pain that restricts daily activities 3. Nocturnal pain 4. Limitation in active and passive range of motion Patients in first stage of disease( Progressive pain and limitation in range of motion from past 3 months.) Patient agreement to enter the trial 30 to 60 years old patients 30 years 60 years Both Patients with history of trauma, surgery, corticosteroid injection or any previous injury to the shoulder Patients who had received other treatments including surgical or nonsurgical treatments prior to entering the trial M75.0 Adhesive capsulitis of shoulder Treatment - Drugs N/A Intervention group: this group receives nasal calcitonin spray. It should be used with dosage of one puff daily for 8 weeks. Control group: this group does not receive calcitonin spray. Pain severity. Timepoint: Before starting the intervention, 2 months and 6 months after starting the intervention. Method of measurement: By Visual Analogue Scale( VAS ). Shoulder range of motion. Timepoint: Before starting the intervention, 2 months and 6 months after starting the intervention. Method of measurement: By physical examination. Esfahan University of Medical Sciences Approved 2021-03-19 Ethics committee of Isfahan university of medical science No 38, 2nd alley, Mollasadra St. Isfahan Isfehan Iran (Islamic Republic of)