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

NCT ID: NCT01781130

Last Updated: 2015-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-06-30

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

Conditions

Trigger Finger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Percutaneous release alone

The patients who perform percutaneous release of trigger finger only

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Percutaneous release + Steroid injection

Steroid local injection after percutaneous release of trigger finger

Group Type: EXPERIMENTAL

Steroid injection

Intervention Type: PROCEDURE

Interventions

Steroid injection

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Min Jong Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 9018629 (View on PubMed)

Other Identifiers

2012-11-112-002

Identifier Type: -

Identifier Source: org_study_id