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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01781130

Collaborator

(none)

112

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Trigger Finger	Procedure: Steroid injection	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

pain VAS [3 month after procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Patel MR, Moradia VJ. Percutaneous release of trigger digit with and without cortisone injection. J Hand Surg Am. 1997 Jan;22(1):150-5.

Responsible Party:

Min Jong Park, Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01781130

Other Study ID Numbers:

2012-11-112-002

First Posted:

Jan 31, 2013

Last Update Posted:

May 18, 2015

Last Verified:

May 1, 2015

Additional relevant MeSH terms:

Trigger Finger Disorder

Study Results

No Results Posted as of May 18, 2015