Effectiveness of corticosteroid injection in treatment of trigger fingers: a double blinded randomized clinical trial

Phase 4

Completed

Conditions: tenosynovitis
triggerfinger
10043237

Registration Number: NL-OMON54114

Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- One or more trigger fingers
- Grade 1-3 trigger finger (according to classification by Quinnell)
- Participation is voluntary and with informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Aged <18
- Congenital trigger finger
- Mentally disabled persons
- Grade 4 trigger finger (according to classification by Quinell)
- Allergy for corticosteroids
- Previous surgical release for triggering
- Previous injection therapy
- History of surgical intervention in the same digit
- Current pregnancy of breast-feeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: The primary outcome to be determined is the success rate of<br /><br>Kenalog-40, Kenalog-10 and Depo-Medrol 40 mg/ml in the treatment of a trigger<br /><br>finger. Success rate is defined as no persistent or recurrence (Quinell 0) of a<br /><br>trigger finger one year after injection (maximum three injections). In<br /><br>addition, the amount of injections needed to achieve Quinnell 0 or the amount<br /><br>of conversions to an operative treatment will be determined for each<br /><br>corticosteroid type of injection. We hypothesize that Depo-Medrol 40 mg/ml has<br /><br>the highest success rate (considering rate of persistence, recurrence and<br /><br>amount of injections and conversion to an operative treatment) and Kenalog-10<br /><br>is lowest success rate. We expect less difference between Depo-Medrol 40 mg/ml<br /><br>and Kenalog-40 than between Kenalog-40 and Kenalog-10. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives:<br /><br><br /><br>- Difference in patient reported outcomes (MHOQ, TFQ and NRS scores)<br /><br>- To test the validity and reliability of the Trigger Finger Questionnaire<br /><br>- Difference in ROM before and two months after injection<br /><br>- difference in costs<br /><br>- difference in number and kind of complications</p><br>