1. Home
  2. Approved trials
  3. » فارسی

Efficacy of Botulinum Toxin A Injection for Raynaud's Phenomenon and digital ulcers in patients with systemic sclerosis (scleroderma)

Protocol summary

Study aim
The effect of local botulinum toxin A injection on the improvement of symptoms of Raynaud's phenomenon and digital ulcers in systemic sclerosis
Design
Thirty patients will be included in the study. Non-dominant hands of patients will be used as intervention group and the dominant hands of patients as control group.
Settings and conduct
Before the intervention, patients' demographic information and the results of physical examinations will be recorded. Then Quick DASH, pain score (VAS) and Raynaud's condition score (RCS) questionnaires will be completed. Then, 50 units of botulinum toxin 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). In the other hand, only normal saline will be injected in the same way. At end of months 1 and 4, patients will be reassessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: scleroderma diagnosis based on the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR), age>18 years, bilateral Raynaud's phenomenon with an intensity of greater than 50 according to the Raynaud's condition score (RCS), pain intensity greater than 5 based on visual analog scale (VAS), dysfunction of the arm, shoulder and hand more than 50 according to the Quick Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. Exclusion criteria: Active infection in the hands, history of any botulinum toxin allergy, history of upper extremity vascular surgery, history of sympathectomy, pregnancy, breast feeding
Intervention groups
In the non-dominant hand, botulinum toxin A and into the dominant hand of each patient (as control), normal saline will be injected.
Main outcome variables
Symptoms of Raynauds's phenomenon; pain intensity; dysfunction of the arm, shoulder and hand

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20081202001479N7
Registration date: 2018-12-29, 1397/10/08
Registration timing: prospective

Last update: 2018-12-29, 1397/10/08
Update count: 0
Registration date
2018-12-29, 1397/10/08
Registrant information
Name
Mohammadhassan Jokar
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 8818
Email address
jokarmh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-04-09, 1398/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Botulinum Toxin A Injection for Raynaud's Phenomenon and digital ulcers in patients with systemic sclerosis (scleroderma)
Public title
Botox in the treatment of Raynaud's phenomenon in scleroderma
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
In this study, we will inject botulinum toxin A into the non-dominant hands and normal saline (as placebo) into the dominant hands of patients.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University for Medical Science
Street address
Mashhad University for Medical Science, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2018-10-31, 1397/08/09
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.334

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
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 outcomes

1

Description
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

2

Description
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)

Intervention groups

1

Description
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.
Category
Placebo

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, Mashhad
Full name of responsible person
Dr Mohammadhassan Jokar
Street address
Chamran street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 8818
Email
jokarmh@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah street, Vice-Chancellor for Research of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
Tafaghodim@mums.ac.ir
Grant name
Grant of Research Project of Vice-Chancellor for Research of Mashhad University of Medical Sciences
Grant code / Reference number
961794
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadhassan Jokar
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Chamran street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 8818
Email
jokarmh@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Hassan Jokar
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Chamran St. Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 8818
Email
jokarmh@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Hassan Jokar
Position
MD, Rheumatologist, Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine ward, Imam Reza Hospital, Chamran street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3859 8818
Fax
+98 51 3859 8818
Email
jokarmh@mums.ac.ir
Web page address
http://my.mums.ac.ir/default.aspx

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...