Satisfaction and Recovery After Trigger Finger Release (TH III)

November 26, 2024 updated by: Joakim Stromberg, Sahlgrenska University Hospital, Sweden

Satisfaction and Recovery After Trigger Finger Release- a Prospective Cohort Study With Weekly PROMs

Trigger finger release is one of the most common procedures in hand surgery. However, little is known about the patient perceived outcome directly after surgery and the timespan to recovery of normal hand function.This study focuses on patient reported outcome scores within the first six weeks after surgery.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Patients scheduled for release of trigger finger are assessed regarding the following outcome measures:

  1. VAS score for pain
  2. VAS score for finger movement
  3. VAS score for fréquence of triggering
  4. HAKIR questionnaire (validated instrument for hand function in the Swedish national hand registry)
  5. Quick-DASH questionnaire.

After surgery, the patients records the following outcomes:

Each day: 1,2,3 and records of pain medication details Each week: 4,5

for 6 weeks

Study Type

Observational

Enrollment (Actual)

110

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

      • Alingsås, Sweden
        • Alingsas lasarett

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Patient scheduled for trigger finger release

Description

Inclusion Criteria:

  1. Trigger phenomenon and/or
  2. Tenderness volarly to MCP joint of affected finger/thumb
  3. Patient scheduled for trigger finger release
  4. Signed informed consent

Exclusion Criteria:

  1. Concomitant hand injuries/ conditions
  2. Multiple fingers/thumbs to be treated
  3. Unable to read/understand instructions in Swedish

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-assessed hand function
Time Frame: every week for 6 weeks
change in total score of hand-specific questionnaire (HAKIR) week by week. Best score 100, worst 0
every week for 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (assessed by patient)
Time Frame: 6 weeks
change in Visual Analouge Scale-score day by day (0= worst, 10=best)
6 weeks
Movement of finger (self-assessed by patient)
Time Frame: 6 weeks
change in Visual Analouge Scale-score day by day (0= worst, 10=best)
6 weeks
Frequency of trigger phenomenon (self-assessed by patient)
Time Frame: 6 weeks
change in Visual Analouge Scale-score day by day (0= worst, 10=best)
6 weeks

Collaborators and Investigators

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

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)

April 26, 2022

Primary Completion (Actual)

November 26, 2024

Study Completion (Actual)

November 26, 2024

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • TriggerHappy III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

open repositry

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.

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