Back to resultsThe TriggerHappy Trial (Triggerhappy)
Primary Purpose
Trigger Finger, Trigger Thumb, Minimally Invasive Surgery
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Proximal phalangeal level
Volar to the MCP-joint
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger
Eligibility Criteria
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
Sites / Locations
- Alingsås Lasarett/ District Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
proximal phalangeal level
volar MCP level
Arm Description
injection in the the tendon sheet over proximal phalanx of finger
injection above the A1 pulley volar to the MCP joint
Outcomes
Primary Outcome Measures
Pain after injection
Visual analouge scale (VAS), range 0-10, where 0 indicates "no pain" and 10 "maximum pain"
Impairment of finger motion
Visual analouge scale (VAS), range 0-10, where 0 indicates "no impairment" and 10 "maximum impairment"
Triggering
Visual analouge scale (VAS), range 0-10, where 0 indicates "no trigger phenomenon" and 10 "Trigger phenomenon all the time/ locked finger"
Secondary Outcome Measures
Quick-DASH
generic handquestionaire, 11 items, 0 means normal hand function, 100 most impaired function
Full Information
NCT ID
NCT04568993
First Posted
September 23, 2020
Last Updated
January 10, 2023
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT04568993
Brief Title
The TriggerHappy Trial
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger, Trigger Thumb, Minimally Invasive Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
proximal phalangeal level
Arm Type
Experimental
Arm Description
injection in the the tendon sheet over proximal phalanx of finger
Arm Title
volar MCP level
Arm Type
Active Comparator
Arm Description
injection above the A1 pulley volar to the MCP joint
Intervention Type
Procedure
Intervention Name(s)
Proximal phalangeal level
Intervention Description
Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx
Intervention Type
Drug
Intervention Name(s)
Volar to the MCP-joint
Intervention Description
Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint
Primary Outcome Measure Information:
Title
Pain after injection
Description
Visual analouge scale (VAS), range 0-10, where 0 indicates "no pain" and 10 "maximum pain"
Time Frame
Four weeks
Title
Impairment of finger motion
Description
Visual analouge scale (VAS), range 0-10, where 0 indicates "no impairment" and 10 "maximum impairment"
Time Frame
Four weeks
Title
Triggering
Description
Visual analouge scale (VAS), range 0-10, where 0 indicates "no trigger phenomenon" and 10 "Trigger phenomenon all the time/ locked finger"
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Quick-DASH
Description
generic handquestionaire, 11 items, 0 means normal hand function, 100 most impaired function
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alingsås Lasarett/ District Hospital
City
Alingsås
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
The TriggerHappy Trial
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