Objectives: Tenosynovitis of the first extensor compartment is known as De Quervain's disease. While transfusion of autologous blood has been widely used in the treatment of tendinopathy and considerable effect of this treatment has been reported in some investigations, no study has evaluated the effect of autologous blood transfusion on De Quervain's disease. In this study we aim to evaluate the therapeutic effect of autologous blood transfusion on De Quervain's disease.
Design: Randomized controlled clinical trial
Setting and conduct: A total number of 30 patients with confirmed diagnosis of De Quervain's disease made by a hand surgeon will be equally divided into intervention and control group.
Inclusion criteria: Diagnosis of De Quervain's disease; age of 18 to 60 years; no history of rheumatic disorder such as rheumatoid arthritis; no history of depression and other mental disorders; no history of previous intervention for the treatment of De Quervain's disease.
Exclusion criteria: loss of follow-up.
Main outcome measures: Pain and disability level of the disease will be evaluated using visual analog scale and Persian version of Disabilities of the Arm, Shoulder and Hand (DASH) score once before the start of intervention and once 6 weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081635382N4
Registration date:2017-08-16, 1396/05/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Farid Najd Mazhar
Name of organization / entity
Shafa orthopedic hospital, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2000
Email address
najdmazhar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For research of Iran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of autologous blood transfusion on the treatment of De Quervain's tenosynovitis
Public title
Effect of autologous blood transfusion on the treatment of De Quervain's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of De Quervain's disease; age of 18 to 60 years; no history of rheumatic disorder such as rheumatoid arthritis; no history of depression and other mental disorders; no history of previous intervention for the treatment of De Quervain's disease.
Exclusion criteria: loss of follow-up.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Next to Milad tower, Hammat Highway
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
-
Health conditions studied
1
Description of health condition studied
De Quervain's
ICD-10 code
M65.4
ICD-10 code description
Spontaneous rupture of synovium and tendon
Primary outcomes
1
Description
Pain
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
visual analog scale
2
Description
Disability
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Disabilities of the Arm, Shoulder and Hand (DASH) score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of patients 1 CC autologous blood of the patient will be transfused at the site of affected tendon.
Category
Treatment - Other
2
Description
Control group: In this group of patients placebo (normal saline) will be injected instead of autologous blood transfusion.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Orthopedic Hospital
Full name of responsible person
Farid Najd Mazhar
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Morteza Naserbakht
Street address
Next to Milad tower, Hemmat Highway.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shafa Orthopedic Hospital
Full name of responsible person
Farid Najd Mazhar
Position
Orthopedic surgeon/Science committee
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square