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

NCT01781130 | Completed DMC

• 1 other identifier: 2012-11-112-002
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• pain VAS

  3 month after procedure

Study Arms (2)

Percutaneous release alone

PLACEBO COMPARATOR

The patients who perform percutaneous release of trigger finger only

Percutaneous release + Steroid injection

EXPERIMENTAL

Steroid local injection after percutaneous release of trigger finger

Procedure: Steroid injection

Interventions

Steroid injection PROCEDURE

Percutaneous release + Steroid injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trigger finger patients who require surgical intervention due to failuer of sufficient time of conservative treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 9018629 BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Steroids

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 31, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

KR (1)