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

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ClinicalTrials.gov Identifier: NCT01781130
Recruitment Status : Completed
First Posted : January 31, 2013
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
Min Jong Park, Samsung Medical Center

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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



Primary Outcome Measures :
  1. pain VAS [ Time Frame: 3 month after procedure ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781130


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

Publications:
Responsible Party: Min Jong Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01781130     History of Changes
Other Study ID Numbers: 2012-11-112-002
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases