Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.
Primary Purpose
Trigger Finger
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger
Eligibility Criteria
Inclusion Criteria:
- Trigger finger patients who require surgical intervention due to failuer of sufficient time of conservative treatment
Exclusion Criteria:
- Age under 18 years old
- Rheumatoid arthritis patients
- Patients who got steroid injection more than 4 times previously
- Multiple finger affected at presentation
- Previous surgery history
- Any recent trauma history of affected hand
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Percutaneous release alone
Percutaneous release + Steroid injection
Arm Description
The patients who perform percutaneous release of trigger finger only
Steroid local injection after percutaneous release of trigger finger
Outcomes
Primary Outcome Measures
pain VAS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01781130
Brief Title
Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background
Present treatment strategies for trigger finger when conservative management including steroid injection was failed include percutaneous or open A1 pulley release, but some people showed prolonged swelling and delay of complete healing.
We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid injection simultaneously with percutaneous release compared with conventional percutaneous release alone
Methods
We designed a double-blind, randomized controlled trial.
Inclusion criteria is the patient who has symptom of trigger finger warranted surgical release after sufficient time of conservative treatment.
Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5) Previous surgery history of finger 6); the patients who got steroid injection more than 4 time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.
After power analysis by a statistician, total 40 patients would be required for each group (percutaneous alone group versus percutaneous alone + steroid injection group).
The surgery will be performed by outpatients clinic basis with local injection. Additional steroid injection will be given to half of patients after allocation with randomized selection by permutaed block randomization.
Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary outcome will be proportion of patients with good response (defined as "Perfect" or "much better" as reported by patients).
Follow-up will be conducted 3 weeks and 3 month after index procedure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous release alone
Arm Type
Placebo Comparator
Arm Description
The patients who perform percutaneous release of trigger finger only
Arm Title
Percutaneous release + Steroid injection
Arm Type
Experimental
Arm Description
Steroid local injection after percutaneous release of trigger finger
Intervention Type
Procedure
Intervention Name(s)
Steroid injection
Primary Outcome Measure Information:
Title
pain VAS
Time Frame
3 month after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Trigger finger patients who require surgical intervention due to failuer of sufficient time of conservative treatment
Exclusion Criteria:
Age under 18 years old
Rheumatoid arthritis patients
Patients who got steroid injection more than 4 times previously
Multiple finger affected at presentation
Previous surgery history
Any recent trauma history of affected hand
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
9018629
Citation
Patel MR, Moradia VJ. Percutaneous release of trigger digit with and without cortisone injection. J Hand Surg Am. 1997 Jan;22(1):150-5. doi: 10.1016/S0363-5023(05)80196-0.
Results Reference
background
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Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.
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