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Satisfaction and Recovery After Trigger Finger Release (TH III)

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ClinicalTrials.gov Identifier: NCT05336045
Recruitment Status : Recruiting
First Posted : April 20, 2022
Last Update Posted : November 22, 2023
Sponsor:
Information provided by (Responsible Party):
Joakim Stromberg, Sahlgrenska University Hospital, Sweden

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Trigger Finger Disorder Procedure: trigger finger release

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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Satisfaction and Recovery After Trigger Finger Release- a Prospective Cohort Study With Weekly PROMs
Actual Study Start Date : April 26, 2022
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2024
Groups and Cohorts
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Intervention Details:
  • Procedure: trigger finger release
    The A1 pulley and tendon sheath is divided in local anaestethic through a small incision in the palm

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pain (assessed by patient) [ Time Frame: 6 weeks ]
    change in Visual Analouge Scale-score day by day (0= worst, 10=best)

  2. Movement of finger (self-assessed by patient) [ Time Frame: 6 weeks ]
    change in Visual Analouge Scale-score day by day (0= worst, 10=best)

  3. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient scheduled for trigger finger release
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05336045


Contacts
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Contact: Joakim Strömberg +46768341327 joakim.stromberg@vgregion.se
Contact: Joakim Strömberg joakim.stromberg@vgregion.se

Locations
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Sweden
Alingsås lasarett Recruiting
Alingsås, Sweden
Contact: Joakim Strömberg       joakim.stromberg@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
More Information
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Responsible Party: Joakim Stromberg, senior consultant surgeon, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT05336045    
Other Study ID Numbers: TriggerHappy III
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: November 22, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: open repositry

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases