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IRCT20220611055139N1 IRCT 2022-08-19 Oroumia University of Medical Sciences Comparing the Effect of Betamethasone and Ketorolac Injection on Treatment of De Quervain`s Tenosynovitis Comparing the Effect of Betamethasone and Ketorolac Injection on Treatment of De Quervain`s Tenosynovitis in Diabetic Patients 2022-08-10 anticipated 60 Complete https://irct.ir/trial/64145 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample size of 60 patients was divided into 10 blocks with different random sizes of 4, 6 and 8 (3 blocks of 4, 4 blocks of 6, 3 blocks of 8) using the Permuted block randomization method by Excel computer software. Then the people of each block are randomly and equally divided into two groups under treatment A or B, and finally 30 patients will be treated with A and 30 patients will be treated with B, Blinding description: Considering the proven effectiveness of both betamethasone and ketorolac in the treatment of De Quervains patients, in a randomized and double-blind manner, neither the treating doctor nor the patient knows about the drug in the syringe, and the preparation and recording of information is the responsibility of the physician's assistant who It is aware. 3 De Quervains tenosynovitis. Intervention 1: First Intervention group: Local injection of 1 cc betamthasone (1cc/4 mg-Darou Pakhsh Pharmaceutical Manufacturing Company) with 1 cc Lidocaine 2% approximately 2 cm proximal to radius styloid، in first extensor tendons compartment of wrist. Intervention 2: Second Intervention group: Local injection of 1 cc ketorolac (1cc/30 mg-Darou Pakhsh Pharmaceutical Manufacturing Company) with 1 cc Lidocaine 2% approximately 2 cm proximal to radius styloid، in first extensor tendons compartment of wrist. 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 There is no further information
public Mehdi Zare
Imam Khomeini hospital, Ershad Blvd.
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3345 9538 Zare.mehdi8911215083@gmail.com Oroumia University of Medical Sciences scientific Mehdi Zare
Imam Khomeini hospital, Ershad Blvd.
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3345 9538 Zare.mehdi8911215083@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) De Quervains Tenosynovitis Patients Diabetes mellitus Type 2 Patients Persons more than 18 yo ages 18 years no limit Both History of Allergic Reaction to Lidocaine ،Ketorolac (and other NSAIDs) ،Aspirin and Betamethasone History of Corticosteroids Injection in past 3 months History of surgery due to De Quervain`s Tenosynovitis in same wrist Pregnant ،Breastfeeding period and Patient with Gestational Diabetes Skin complications such as wounds, eczema or rash at the injection site Active infection at the injection site History of acute wrist trauma, history of wrist fracture, rheumatoid arthritis, uncontrolled diabetes Patients with type 1 diabetes M65.4 Radial styloid tenosynovitis [de Quervain] Treatment - Drugs Treatment - Drugs First Intervention group: Local injection of 1 cc betamthasone (1cc/4 mg-Darou Pakhsh Pharmaceutical Manufacturing Company) with 1 cc Lidocaine 2% approximately 2 cm proximal to radius styloid، in first extensor tendons compartment of wrist Second Intervention group: Local injection of 1 cc ketorolac (1cc/30 mg-Darou Pakhsh Pharmaceutical Manufacturing Company) with 1 cc Lidocaine 2% approximately 2 cm proximal to radius styloid، in first extensor tendons compartment of wrist The amount of pain described by the patient. Timepoint: first session, 6 week, 3 months ,6 months after injection. Method of measurement: Visual Analogue Scale Score. Oroumia University of Medical Sciences Approved 2022-05-24 Ethics committee of Urmia University of Medical Sciences Imam Khomeini Hospital, Ershad Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)