The TriggerHappy Trial (Triggerhappy)
Patient-reported Outcome After Corticoid Injection for Triggerfinger- a Randomized Controlled Study Between Two Injection Procedures and Between Corticoid Injection and Percutaneous Release
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alingsås, Sweden
- Alingsås Lasarett/ District Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: proximal phalangeal level
injection in the the tendon sheet over proximal phalanx of finger
|
Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx
|
|
Active Comparator: volar MCP level
injection above the A1 pulley volar to the MCP joint
|
Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain after injection
Time Frame: Four weeks
|
Visual analouge scale (VAS), range 0-10, where 0 indicates "no pain" and 10 "maximum pain"
|
Four weeks
|
|
Impairment of finger motion
Time Frame: Four weeks
|
Visual analouge scale (VAS), range 0-10, where 0 indicates "no impairment" and 10 "maximum impairment"
|
Four weeks
|
|
Triggering
Time Frame: Four weeks
|
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
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick-DASH
Time Frame: Four weeks
|
generic handquestionaire, 11 items, 0 means normal hand function, 100 most impaired function
|
Four weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- The TriggerHappy Trial
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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