Trigger Finger DisorderTH IIINCT05336045
Satisfaction and Recovery After Trigger Finger Release
An observational study of Trigger Finger Disorder, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigger Finger Disorder
- What is being tested?
- trigger finger release
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- 26 Apr 2022to 26 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient scheduled for trigger finger release
Who may be able to join
- Trigger phenomenon and/or
- Tenderness volarly to MCP joint of affected finger/thumb
- Patient scheduled for trigger finger release
- Signed informed consent
Who cannot join
- Concomitant hand injuries/ conditions
- Multiple fingers/thumbs to be treated
- Unable to read/understand instructions in Swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Trigger Finger Disorder
- Being tested
- trigger finger release
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trigger finger releaseProcedure or surgery
The A1 pulley and tendon sheath is divided in local anaestethic through a small incision in the palm
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessed hand function
change in total score of hand-specific questionnaire (HAKIR) week by week. Best score 100, worst 0
Measured: every week for 6 weeks
Secondary outcomes (3)
Pain (assessed by patient)
change in Visual Analouge Scale-score day by day (0= worst, 10=best)
Measured: 6 weeks
Movement of finger (self-assessed by patient)
change in Visual Analouge Scale-score day by day (0= worst, 10=best)
Measured: 6 weeks
Frequency of trigger phenomenon (self-assessed by patient)
change in Visual Analouge Scale-score day by day (0= worst, 10=best)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start26 Apr 2022
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Finger DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joakim Stromberg, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336045
- Sponsor's protocol ID
- TriggerHappy III
- Acronym
- TH III
- Status last verified
- Nov 2023
- First submitted
- 6 Apr 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: open repositry
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction and Recovery After Trigger Finger Release- a Prospective Cohort Study With Weekly PROMs
- ClinicalTrials.gov ID
- NCT05336045
- Acronym / sponsor ID
- TH III / TriggerHappy III
- Conditions
- Trigger Finger Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient scheduled for trigger finger release
Key inclusion criteria (4 listed)
- Trigger phenomenon and/or
- Tenderness volarly to MCP joint of affected finger/thumb
- Patient scheduled for trigger finger release
- Signed informed consent
Key exclusion criteria (3 listed)
- Concomitant hand injuries/ conditions
- Multiple fingers/thumbs to be treated
- Unable to read/understand instructions in Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trigger finger releaseThe A1 pulley and tendon sheath is divided in local anaestethic through a small incision in the palm | Procedure or surgery | – |
Primary outcome
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
3 secondary outcomes
Pain (assessed by patient)
Time frame: 6 weeks
Movement of finger (self-assessed by patient)
Time frame: 6 weeks
Frequency of trigger phenomenon (self-assessed by patient)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: Undecided. open repositry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigger Finger Disorder, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-assessed hand function (time frame: every week for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.