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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Min Jong Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01781130
First received: January 15, 2013
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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 Intervention
Trigger Finger
Procedure: Steroid injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • pain VAS [ Time Frame: 3 month after procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781130

Contacts
Contact: Min Jone Park, MD 82-2-3410-3509 lhi76@naver.com

Locations
Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyunil Lee, MD       anakin76@nate.com   
Principal Investigator: Min Jong Park, MD         
Sponsors and Collaborators
Samsung Medical Center
  More Information

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
Study First Received: January 15, 2013
Last Updated: January 29, 2013
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014