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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)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20081202001479N7
Enrollment
30
Registered
2018-12-29
Start date
2019-01-10
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic sclerosis (scleroderma). Systemic sclerosis [scleroderma]

Interventions

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

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadhassan Jokar

Mashhad University of Medical Sciences

jokarmh@mums.ac.ir+98 51 3859 8818

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026