Determine the effect of the injection of methylprednisolone and diclofenac sodiumin the treatment of patients with trigger finger
Design
In this study, 84 patients have been assigned to two groups of intervention and control by using random numbers table.
Settings and conduct
In this clinical trial, all patients who undergo surgery in Shahid Beheshti Hospital with trigger finger diagnosis include the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes Patients age 21-65 years old with Trigger Finger Informed consent of patient in the study. Exclusion criteria include failure to follow the patient , patients who had a history of allergy to diclofenac or methylprednisolone, pregnant or lactating patients and patients who have had a history of injection drug in the same finger.
Intervention groups
One group was treated with Injected steroids and another group with Injected diclofenac sodium.
Main outcome variables
Quinel Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160508027797N6
Registration date:2019-11-24, 1398/09/03
Registration timing:registered_while_recruiting
Last update:2019-11-24, 1398/09/03
Update count:0
Registration date
2019-11-24, 1398/09/03
Registrant information
Name
Masoud Bahrami Ferydoni
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
m.bahrami@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-25, 1398/06/03
Expected recruitment end date
2020-08-24, 1399/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of methyl prednisolone Injection versus diclofenac Injection in Treatment of Trigger Finger
Public title
Methyl prednisolone Injection versus diclofenac Injection in Treatment of Trigger Finger
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 65-95 years Patients with Trigger Finger
Informed consent of patient in the study
Exclusion criteria:
Patients who had a history of allergy to Diclofenac or Methylprednisolone.
Pregnant or lactating patients and patients who have had a previous history of injection on the same finger.
Failure to follow the patient
Age
From 21 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two groups of Control and intervention using Permuted Block Randomization. Number will be selected for allocation concealment by one of the colleagues and by another, that assignment chain is chosen.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug is injected in a double-blind manner so that the drugs are prepared by the researcher and given to the treating physician and the injection is given in aseptic conditions.
Examination, drug injection, evaluation of treatment outcome based on the severity of the disease based on Quinnell classification will be compared between the two groups and will be performed by the researcher if needed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2019-08-24, 1398/06/02
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.170
Health conditions studied
1
Description of health condition studied
Trigger Finger
ICD-10 code
M65.30
ICD-10 code description
Trigger finger, unspecified finger
Primary outcomes
1
Description
Decrease in Quinnell grade
Timepoint
3 and 6 weeks, 3 and 6 and 12 months after the first injection
Method of measurement
Quinnell grading
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Medicines from Abaidi Company are selected for all patients equally. Hemoglobin A1C is measured before treatment was started. 20 mg methylprednisolone acetate injection will be.
Category
Treatment - Drugs
2
Description
Control group: Medicines from Abaidi Company are selected for all patients equally. Hemoglobin A1C is measured before treatment was started. 12.5 mg diclofenac sodium injection will be.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Drbahrami865@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. Sasan Mohammadi Jami
Position
Resident
Latest degree
Medical doctor
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
jamisasan@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
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
Drbahrami865@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Masoud Bahrami Ferydoni
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 6585
Email
Drbahrami865@gmail.com
Web page address
http://www.mubabol.ac.ir/
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