Comparison of the efficacy of local autologous blood and corticosteroid injection on pain and function in patients with Tennis elbow
Design
A total of 60 patients were divided into 3 groups. One group injected at the site of lateral epicondyle with steroid (methyl prednisolone acetate-40mg) and another group with autologous blood (2ml of venous blood). And the other group used a brace for 3 weeks
Settings and conduct
A clinical trial study conducted in Shahid Beheshti Hospital of Babol
Participants/Inclusion and exclusion criteria
Inclusion criteria : All patients with tennis elbow disease that referring to the hospital
Exclusion criteria: patients with history of RA, history of elbow fracture, past medical injection in elbow and patients with long term using of streoid
Intervention groups
One group injected at the site of lateral epicondyle with steroid
Another group with autologous blood
The other group used brace
Main outcome variables
Determine preferred treatment with better function and less pain to prevent complications and relapse after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180422039382N2
Registration date:2019-03-10, 1397/12/19
Registration timing:retrospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Rahmatollah Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
r.jokar@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-05, 1397/04/14
Expected recruitment end date
2018-08-05, 1397/05/14
Actual recruitment start date
2018-07-05, 1397/04/14
Actual recruitment end date
2018-07-20, 1397/04/29
Trial completion date
2018-11-20, 1397/08/29
Scientific title
Comparison of the efficacy of local autologous blood and corticosteroid injection on pain and function in patients with Tennis elbow
Public title
Comparison of the efficacy of local autologous blood and corticosteroid injection on pain and function in patients with Tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with tennis elbow who cِame to the hospital
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by using statistical software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Iran, Mazandaran, Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2018-07-05, 1397/04/14
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.074
Health conditions studied
1
Description of health condition studied
Tennis elbow or Lateral epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis
Primary outcomes
1
Description
Pain and function
Timepoint
Day 0; Day 15; Day 30; Day 90
Method of measurement
Evaluation with Patient-Rated Tennis Elbow Evaluation
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: patients who have been injected Corticosteroid (methyl prednisolone acetate-40mg) at the site of lateral epicondyle
Category
Treatment - Drugs
2
Description
Second intervention group: patients who have been injected autologous blood (2ml of venous blood) at the site of lateral epicondyle
Category
Treatment - Drugs
3
Description
Third intervention group: One group used a brace for 3 weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital of Babol
Full name of responsible person
ِDr. Rahmatollah Jokar
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Dr.Jokar1@gmail.com
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3219 7667
Email
Rezaghadimi@yahoo.com
Web page address
Http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Raheleh Javer
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Babol University of Medical Sciences; Ganjafrooz street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Bluesky9344@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Rahmatollah Jokar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Dr.Jokar1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Rahmatollah Jokar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Dr.Jokar1@gmail.com
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