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IRCT20081202001479N7 IRCT 2018-12-29 Mashhad University of Medical Sciences Botox in the treatment of Raynaud's phenomenon in scleroderma Efficacy of Botulinum Toxin A Injection for Raynaud's Phenomenon and digital ulcers in patients with systemic sclerosis (scleroderma) 2019-01-10 anticipated 30 Complete https://irct.ir/trial/35696 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 4 systemic sclerosis (scleroderma). Intervention 1: Control group: ِDominant hands of the patients. Normal saline (total volume 2.5 cc) with insulin syringe will be injected into the following sites: second-forth interdigital webs، base of thumb, second and fifth fingers. Injection will only be done once. Intervention 2: Intervention group: Non-dominant hands of patients. Fifty units of botulinum toxin (DYSPORT®, IPSEN, UK ) will be mixed with 2.5 cc of normal saline. The injection sites are: second-forth interdigital webs (each one 10 units)، base of thumb (10 units) , second and fifth fingers (each 5 units). Injection will only be done once. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammadhassan Jokar
Chamran street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3859 8818 jokarmh@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammad Hassan Jokar
Chamran St. Imam Reza Hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3859 8818 jokarmh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Scleroderma diagnosis based on the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) criteria age>18 years Bilateral Raynaud's phenomenon with an intensity greater than 50 according to the Raynaud's condition score (RCS) questionnaire ِDysfunction of the arm and shoulder and arm more than 50 according to the Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire Pain intensity greater than 5 based on visual analog scale (VAS) 18 years no limit Both Active infection in any of the hands History of any botulinum toxin allergy History of upper extremity vascular surgery History of sympathectomy Pregnancy Breast feeding M34 Systemic sclerosis [scleroderma] Placebo Treatment - Drugs Control group: ِDominant hands of the patients. Normal saline (total volume 2.5 cc) with insulin syringe will be injected into the following sites: second-forth interdigital webs، base of thumb, second and fifth fingers. Injection will only be done once. Intervention group: Non-dominant hands of patients. Fifty units of botulinum toxin (DYSPORT®, IPSEN, UK ) will be mixed with 2.5 cc of normal saline. The injection sites are: second-forth interdigital webs (each one 10 units)، base of thumb (10 units) , second and fifth fingers (each 5 units). Injection will only be done once. Raynaud's phenomenon symptoms. Timepoint: At the beginning of study and end of months 1 and 4. Method of measurement: Raynaud's phenomenon condition score Questionnaire. Ulcers of fingers. Timepoint: At the beginning and end of months 1 and 4. Method of measurement: Counting the number of ulcers and measuring the diameter of the ulcers. Disabilities of the Arm, Shoulder and Hand. Timepoint: At the beginning of study and end of months 1 and 4. Method of measurement: Disabilities of the Arm, Shoulder and Hand Score(QuickDash). Mashhad University of Medical Sciences Approved 2018-10-31 Ethics committee of Mashhad University for Medical Science Mashhad University for Medical Science, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)