Assessment of botulinum toxin type A effect on Intensified Raynauds Phenomenon in Sclerodermic patients
Design
This study will be a double blind clinical trial. Eleven scleroderma patients with intensified Raynauds will be randomly assigned to receive 50 units of botulinum toxin A in one hand (intervention group) and normal saline in the other hand (placebo group).
Settings and conduct
scleroderma patients with intensified Raynauds referred to the rheumatology clinic of Imam Khomeini Hospital in Urmia will be enrolled. In one hand, 50 units of botulinum toxin A as an intervention and in the other hand normal saline will be injected. In this way, 10 units of Botox A will be injected for each of the inter-finger space of second, three and four fingers at two separate points near each finger and also for the inter-finger space between the radial surface of second finger and the ulnar surface of fifth finger, finally at both the radial and ulnar surface of thumb finger five units of Botox will be injected. totally, 50 units of Botox will be injected. The same volume of normal saline will be injected into the other hand. Patients will be followed one and two months after the injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosed scleroderma ccording to American college of Rheumatology criteria; Age over 18 years;
severe and resistance Raynauds to oral therapy.
Exclusion criteria: Myasthenia gravis disease; Pregnancy and lactation; History of vascular surgery and surgical sympathectomy; Currently use of Aminoglycosides; Presence of Active infection
Intervention groups
fifty units of botulinum toxin as intervention and normal saline.
Main outcome variables
The Raynauds activity; Number of new wounds
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200106046023N1
Registration date:2020-03-20, 1399/01/01
Registration timing:retrospective
Last update:2020-03-20, 1399/01/01
Update count:0
Registration date
2020-03-20, 1399/01/01
Registrant information
Name
Seyedmostafa Seyedmardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
mardani.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-18, 1397/11/29
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-09-22, 1398/06/31
Trial completion date
2019-09-22, 1398/06/31
Scientific title
Assessment of the botulinum toxin type A effect on Intensified Raynauds Phenomenon in Sclerodermic patients
Public title
Assessment of the botulinum toxin type A effect on Intensified Raynauds Phenomenon in Sclerodermic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with scleroderma based on ACR criteria
Patients with Age over 18 years
Intensified and Resistant Raynauds
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
11
More than 1 sample in each individual
Number of samples in each individual:
1
Right hand and left hand
Actual sample size reached:
11
Randomization (investigator's opinion)
Randomized
Randomization description
The hands of each patients were randomly divided into intervention and control groups. In this way, based on random number table, even numbers were considered as intervention hand and odd numbers as control hand.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, researcher and subject who evaluated the outcomes of study were unaware from intervention and placebo group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
No. 14000245577, Resalat street., Jahad Blvd., Urmia University of Medical Sciences., Urmia., Iran.
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
ir.umsu.rec.1397.192
Health conditions studied
1
Description of health condition studied
Systemic sclerosis [scleroderma]
ICD-10 code
M34
ICD-10 code description
Systemic sclerosis [scleroderma]
Primary outcomes
1
Description
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.
2
Description
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 outcomes
1
Description
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.
2
Description
Pain
Timepoint
Before intervention, one and two months after injection of botulinum toxin A
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Fifty units of botulinum toxin A