Protocol summary

Study aim
Comparison of treatment results of trigger finger by Corticosteroid injection and Percutaneous release
Design
Clinical trial with randomized parallel groups
Settings and conduct
Patients with trigger finger referred to Baghaei poor polyClinic and Khatam al anbia Yazd,entered the study according to inclusion criteria and after obtaining informed consent randomly assigned to one of the groups injection of steroid or Percutaneous release And are evaluated at specified intervals after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, Patients with informed consent, Patients with trigger finger symptoms based on the QUINNELL scale and Patients with no history of any previous finger surgery. Exclusion criteria: Patients with hand tendon disorders.
Intervention groups
Intervention group: First with lidocaine 2% local anesthesia is performed and then the needle of the gage 18 is inserted through the anatomical site and attempts to release percutaneously by vertical movements over the A1 pulley. Control group: Patients in this group will receive xylocaine 0.9 cc, bicarbonate 0.1 cc and 1 cc methylprednisolone.
Main outcome variables
Primary outcomes: Assessing the finger movement Secondary outcomes: Pain after intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180627040252N1
Registration date: 2019-12-19, 1398/09/28
Registration timing: retrospective

Last update: 2019-12-19, 1398/09/28
Update count: 0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
Abbas Abdoli Tafti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3522 2304
Email address
aabdoli2000@mail.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of trigger finger: a randomized clinical trial comparing the methods of corticosteroid injection and percutaneous release
Public title
Treatment of trigger finger
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Patients with informed consent Patients with trigger finger symptoms based on the QUINNELL scale. Patients with no history of any previous finger surgery
Exclusion criteria:
Patients with hand tendon disorders
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using table of random numbers
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
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2018-06-26, 1397/04/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.051

Health conditions studied

1

Description of health condition studied
Trigger finger
ICD-10 code
M65.3
ICD-10 code description
Trigger finger

Primary outcomes

1

Description
Assessing the finger movement
Timepoint
Weeks 1, 3 and 6 and then 3 and 6 months after intervention.
Method of measurement
Physical examination

Secondary outcomes

1

Description
Pain after surgery
Timepoint
1, 3 and 6 weeks and then 3 to 6 months after intervention
Method of measurement
Visual Analogue Scale (VAS)

Intervention groups

1

Description
Intervention group: First with lidocaine 2% local anesthesia is performed and then the needle of the gage 18 is inserted through the anatomical site and attempts to release percutaneously by vertical movements over the A1 pulley.
Category
Treatment - Surgery

2

Description
Control group: Patients in this group will receive xylocaine 0.9 cc, bicarbonate 0.1 cc and 1 cc methylprednisolone.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghaei poor Polyclinic
Full name of responsible person
Dr Abbas Abdoli
Street address
Baghaei poor Polyclinic, Shahid Sadoughi Hospital, Ebne Sina Street, Shahid Ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8915887856
Phone
+98 35 3822 9205
Email
baghaei@ssu.ac.ir
Web page address
http://baghaei.ssu.ac.ir

2

Recruitment center
Name of recruitment center
Khatam Al-Anbia Super Speciality Clinic
Full name of responsible person
Dr Abbas Abdoli
Street address
Taleghani Blvd
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3733 0122
Email
clinic@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Abbas Abdoli Tafti
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hand Surgery
Street address
Shahid Sadougi hospital, Ebne Sina street, Shahid Ghandi BLvd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 9008
Email
aabdoli2000@mail.ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Hashemizadeh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Sadougi hospital, Ebne Sina street, Shahid Ghandi BLvd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 9007
Email
hashemizadeh.masoud@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Hashemi Zadeh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Sadougi hospital, Ebne Sina street, Shahid Ghandi BLvd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 9007
Email
hashemizadeh.masoud@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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