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IRCT20181101041523N1 IRCT 2022-12-20 Yazd University of Medical Sciences Intramuscular methotrexate on adhesive capsulitis of the shoulder Therapeutic efficacy of intramuscular methotrexate versus oral naproxen in adhesive capsulitis of the shoulder: a randomized controlled trial 2019-01-30 anticipated 30 Complete https://irct.ir/trial/49464 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization would be done by allowing the included patients to choose among sealed and opaque envelopes containing the allocation to either of the treatment groups. As diabetes condition is strongly correlated with the disease (presumably 70% of patients with adhesive capsulitis), this parameter has been selected as the factor for stratified randomization. Patients with diabetes condition would choose from 'Diabetes strata' while patients without diabetes condition would choose an envelope from 'Non-Diabetes' strata. 4 Adhesive capsulitis of the shoulder. Intervention 1: Intervention group: Intramuscular methotrexate (12.5 mg every 10 days for 40 days). Intervention 2: Intervention group: Oral Naproxen (500 mg Daily for 40 days). Yes - There is a plan to make this available What will be shared: َAll patient data are handled with their informed consent. No personal data, disclosing patient identities would be shared. IPD collected for the primary outcome measure only When: Three months after publication To whom: We try to publish it in an open-access journal for maximum visibility and accessibility. Conditions: Only for academic purposes, and comparing with other studies, unidentified data would be accessible. Where to obtain: Send an email via sinowlia@gmail.com How to obtain: Valid proof of academic eligibility is necessary. Comments:
public Sina Owlia
Central Administration, Bahonar Sq., Yazd 8916978477 I.R. Iran
Yazd Iran (Islamic Republic of) 8916886938 +98 35 3725 8410 sinowlia@gmail.com Yazd University of Medical Sciences scientific Mohammad Bagher Owlia
Rheumatology Division, Shahid Sadoughi Hospital, Ibn Sina blvd., Safaiyeh, Yazd, Iran
Yazd Iran (Islamic Republic of) 8916886938 +98 35 3822 4000 bagherowlia@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All patients diagnosed with adhesive capusilits older than 18 years old 18 days no limit Both History of trauma Evidence of degenerative processes Active gastric ulcer History of GI bleeding History of hepatitis Patients with renal insufficiency Pregnant women M75.0 Adhesive capsulitis of shoulder Treatment - Drugs Treatment - Drugs Intervention group: Intramuscular methotrexate (12.5 mg every 10 days for 40 days) Intervention group: Oral Naproxen (500 mg Daily for 40 days) Passive range of motion of the involved shoulder (flexion, abduction, internal rotation, external rotation). Timepoint: Before intervention, and at 2, 4, and 8 weeks after intervention. Method of measurement: Analog Goniometer. Perceived pain. Timepoint: Before intervention, and at 2, 4, and 8 weeks after intervention. Method of measurement: Visual Analog Scale. Functional and disability outcomes. Timepoint: Before intervention, and at 2, 4, and 8 weeks after intervention. Method of measurement: Shoulder pain and disability index (SPADI) Questionnaire. Yazd University of Medical Sciences Approved 2020-02-23 Shahid Sadoughi University of Medical Sciences, Ethics Committee School of Medicine, Alem sq., Safaiyeh, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)