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

Samsung Medical Center

Status: Completed

Conditions: Trigger Finger

Treatments: Procedure: Steroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01781130

2012-11-112-002

Details and patient eligibility

About

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

Enrollment: 112 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups, including a placebo group

Percutaneous release alone

Placebo Comparator group

Description:

The patients who perform percutaneous release of trigger finger only

Percutaneous release + Steroid injection

Experimental group

Description:

Steroid local injection after percutaneous release of trigger finger

Treatment:

Procedure: Steroid injection