(1) Objectives: This study seeks to evaluate Therapeutic responses to Subcutaneous versus Intra-sheath sonographically guided corticosteroid injection in the management of Trigger Finger. (2) Design: triple blinded randomized controlled trial. (3) Setting and conduct: after randomization using random block system,1 c.c of "Methyl-prednisolon acetate" 40 milligrams plus 1 c.c of "lidocaine" 2% will be injected in all fingers at the level of A1 puley under sonographic guidance. Injection will execute intra-sheath in control group and subcutaneous in intervention group. (4) Participants including major eligibility criteria: All patients with three symptoms of pain and tenderness at the position of A1 pulley, feeling pain and discomfort when flexing and extending finger, and nodule palpation. Exclusion criteria: Any kind of concomitant local Tenosynovitis such as DeQurvain Disease, carpal tunnel syndrome, and Dupuytren's Contracture; clinical doubt to other diseases with similar symptoms and their affirmation in executed investigations; any history of local injection of corticosteroid; and any associated medical conditions. (5) Intervention: Intervention group: subcutaneous injection, Control group: Intra-sheath injection. (6) Main outcome measures: Measuring alteration of Quinnell's grade.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202187274N3
Registration date:2012-04-04, 1391/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-04, 1391/01/16
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2012-03-05, 1390/12/15
Expected recruitment end date
2013-09-05, 1392/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic responses to Subcutaneous versus Intra-sheath sonographically guided corticosteroid injection in the management of Trigger Finger
Public title
Therapeutic responses to Subcutaneous versus Intra-sheath sonographically guided corticosteroid injection in the management of Trigger Finger
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: having three symptoms of pain and tenderness at the position of A1 pulley, feeling pain and discomfort when flexing and extending finger, and nodule palpation. Exclusion Criteria: Any kind of concomitant local Tenosynovitis such as DeQurvain Disease, carpal tunnel syndrome, and Dupuytren's Contracture; clinical doubt to other diseases with similar symptoms and their affirmation in executed investigations; any history of local injection of corticosteroid; and any associated medical conditions such as diabetes melitus, rheumatoid arthritis and hypothyroidism.
Age
From 14 years old to 149 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
166
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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, Guilan University of Medical Sciences
Street address
Vice chancellor for research, Guilan University of Medical Sciences, Namjou avenue
City
Rasht
Postal code
Approval date
2012-01-11, 1390/10/21
Ethics committee reference number
1901130512
Health conditions studied
1
Description of health condition studied
Trigger Finger
ICD-10 code
M65.3
ICD-10 code description
Trigger finger, Nodular tendinous disease
Primary outcomes
1
Description
Therapeutic response (Decrease in Quinnell's grade)
Timepoint
Before first injection, 3 and 6 weeks, 3 and 6 months and 1 year after first injection
Method of measurement
Quinnell's grade
Secondary outcomes
1
Description
Reinjection
Timepoint
3 and 6 weeks, 3 and 6 months and 1 year after first injection
Method of measurement
Number
2
Description
Open Surgery
Timepoint
6 weeks, 3 and 6 months and 1 year after first injection
Method of measurement
Number
Intervention groups
1
Description
Intervention group: 1 c.c of "Methyl-prednisolon acetate" 40 milligrams plus 1 c.c of "lidocaine" 2% will be injected subcutaneously under sonographic guidance.
Category
Treatment - Other
2
Description
Control group: 1 c.c of "Methyl-prednisolon acetate" 40 milligrams plus 1 c.c of "lidocaine" 2% will be injected intra-sheath under sonographic guidance.