- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05336045
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
Conditions
Intervention / Treatment
Detailed Description
Patients scheduled for release of trigger finger are assessed regarding the following outcome measures:
- VAS score for pain
- VAS score for finger movement
- VAS score for fréquence of triggering
- HAKIR questionnaire (validated instrument for hand function in the Swedish national hand registry)
- 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:
- Trigger phenomenon and/or
- Tenderness volarly to MCP joint of affected finger/thumb
- Patient scheduled for trigger finger release
- Signed informed consent
Exclusion Criteria:
- Concomitant hand injuries/ conditions
- Multiple fingers/thumbs to be treated
- 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
Additional Relevant MeSH Terms
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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