The TriggerHappy Trial

Study Overview
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Brief Summary
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This is a prospective randomized multicenterstudy focusing on PROMs after primary corticoid injection for triggerfinger with a comparison of two different injection techniques.

Detailed Description
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This study aims to compare two different methods of corticosteroid injections in patients with triggerfinger, and to study the effects of these injections by day-to-day self-assessment by the included study persons for four weeks. The patient assess: 1. Pain 2. Motion and 3. Triggering by VAS scale every day for four weeks.

Official Title
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Patient-reported Outcome After Corticoid Injection for Triggerfinger- a Randomized Controlled Study Between Two Injection Procedures and Between Corticoid Injection and Percutaneous Release

Conditions
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Trigger Finger, Trigger Thumb, Minimally Invasive Surgery

Intervention / Treatment
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* Procedure: Proximal phalangeal level
* Drug: Volar to the MCP-joint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:• Triggering of one or more fingers and/or impaired active finger motion and/or pain during active finger motion Localized tenderness volar to the MCP joint of the affected finger The patient seeks treatment Exclusion Criteria: Previous treatment for triggerfinger in the finger to be treated Impaired function of finger due to previous trauma/infection or other condition Suspicion of other cause than triggeriinger/tendovaginitis Patient not able to follow instructions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: proximal phalangeal level<br>injection in the the tendon sheet over proximal phalanx of finger | Procedure: Proximal phalangeal level<br>* Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx<br>|
| Active Comparator: volar MCP level<br>injection above the A1 pulley volar to the MCP joint | Drug: Volar to the MCP-joint<br>* Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after injection | Visual analouge scale (VAS), range 0-10, where 0 indicates no pain and 10 maximum pain | Four weeks | 
| Impairment of finger motion | Visual analouge scale (VAS), range 0-10, where 0 indicates no impairment and 10 maximum impairment | Four weeks | 
| Triggering | Visual analouge scale (VAS), range 0-10, where 0 indicates no trigger phenomenon and 10 Trigger phenomenon all the time/ locked finger | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick-DASH | generic handquestionaire, 11 items, 0 means normal hand function, 100 most impaired function | Four weeks |