The TriggerHappy Trial

Trigger Finger Clinical Trial

— Triggerhappy  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04568993
• Other study ID #: The TriggerHappy Trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:•

1. Triggering of one or more fingers and/or impaired active finger motion and/or pain during active finger motion

2. Localized tenderness volar to the MCP joint of the affected finger

3. The patient seeks treatment

Exclusion Criteria:

1. Previous treatment for triggerfinger in the finger to be treated

2. Impaired function of finger due to previous trauma/infection or other condition

3. Suspicion of other cause than triggeriinger/tendovaginitis

4. Patient not able to follow instructions

Related Conditions & MeSH terms

• Minimally Invasive Surgery
• Trigger Finger
• Trigger Finger Disorder
• Trigger Thumb

Intervention

Procedure:
• Proximal phalangeal level
Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx

Drug:
• Volar to the MCP-joint
Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint

Locations

Country	Name	City	State
Sweden	Alingsås Lasarett/ District Hospital	Alingsås

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain after injection	Visual analouge scale (VAS), range 0-10, where 0 indicates "no pain" and 10 "maximum pain"	Four weeks
Primary	Impairment of finger motion	Visual analouge scale (VAS), range 0-10, where 0 indicates "no impairment" and 10 "maximum impairment"	Four weeks
Primary	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	Quick-DASH	generic handquestionaire, 11 items, 0 means normal hand function, 100 most impaired function	Four weeks