The TriggerHappy Trial (Triggerhappy)

January 10, 2023 updated by: Joakim Stromberg, Sahlgrenska University Hospital, Sweden

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Alingsås, Sweden
        • Alingsås Lasarett/ District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: proximal phalangeal level
injection in the the tendon sheet over proximal phalanx of finger
Procedure: Proximal phalangeal level
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
Drug: 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

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The TriggerHappy Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Trigger Finger

Clinical Trials on Proximal phalangeal level

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe