Systemic sclerosis [scleroderma]. Systemic sclerosis [scleroderma]
Conditions
Interventions
Intervention 1: Intervention group: Fifty units of botulinum toxin A. Intervention 2: Control group: 50 units of normal saline.
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with scleroderma based on ACR criteria Patients with Age over 18 years Intensified and Resistant Raynauds
Exclusion criteria
Exclusion criteria: A history of allergy to Botox History of myasthenia gravis disease Pregnancy and lactation Taking estrogen-containing pills in the last month History of vascular surgery and sympathectomy Consumption of Aminoglycoside Antibiotics The presence of active infection The presence of severe bleeding tendency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Raynauds activity. Timepoint: Before intervention; one and two months after injection of botulinum toxin A. Method of measurement: The Reynolds Activity Score will be measured using a standard questionnaire consisting of 4 subsets, each rated 0-4 score.;Number of new wounds. Timepoint: Before intervention; one and two months after injection of botulinum toxin A. Method of measurement: The number of new wounds in the fingers will be counted by clinical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of fingers wounds. Timepoint: Before intervention, one and two months after injection of botulinum toxin A. Method of measurement: The number of wounds in the fingers will be counted by clinical examination.;Pain. Timepoint: Before intervention, one and two months after injection of botulinum toxin A. Method of measurement: Visual Analogue Scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. SeyedMostafa SeyeMardani
Oroumia University of Medical Sciences
Outcome results
None listed