Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.

Study Overview
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Brief Summary
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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

Conditions
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Trigger Finger

Intervention / Treatment
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* Procedure: Steroid injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Percutaneous release alone<br>The patients who perform percutaneous release of trigger finger only | |
| Experimental: Percutaneous release + Steroid injection<br>Steroid local injection after percutaneous release of trigger finger | Procedure: Steroid injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain VAS |  | 3 month after procedure |