Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.
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
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
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
- pain VAS [ Time Frame: 3 month after procedure ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Percutaneous release alone
The patients who perform percutaneous release of trigger finger only
Experimental: Percutaneous release + Steroid injection
Steroid local injection after percutaneous release of trigger finger
|Procedure: Steroid injection|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781130
|Contact: Min Jone Park, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Not yet recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Hyunil Lee, MD email@example.com|
|Principal Investigator: Min Jong Park, MD|