Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger

Trigger Finger Clinical Trial

Official title:

Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486420
• Other study ID #: M-20110157
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: October 27, 2015
• Start date: January 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Regionshospitalet Silkeborg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Trigger finger Quinell grade IIb-V in digit I-V

Exclusion Criteria:

• Former treatment of Trigger finger in affected digit

• Dupuytrens contracture in affected digit

• Allergies or intolerance to used medications

• Rheumatoid Arthritis

• Insulin dependent Diabetes Mellitus

• Amyloidosis

• Mucopolysaccharidosis

• Already included in study with another digit

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trigger Finger
• Trigger Finger Disorder

Intervention

Procedure:
• Corticosteroid injections
Corticosteroid injections in and around A1-pulley.
• Open surgery
Open A1-pulley release

Locations

Country	Name	City	State
Denmark	Center for Planned surgery - Regionalhospital Silkeborg	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
Jeppe Lange, MD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quinell grade	Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb.; Quinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only.	12 months	No
Secondary	Numerical Rating Scale (NRS) score	Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)	12 weeks	No
Secondary	infection	Infection occurence following either procedure	12 weeks	No