A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger

November 16, 2023 updated by: Waikato Hospital
The purpose of this research is to evaluate the effectiveness of two splint designs in conservative management of trigger finger.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study aims to analyse and compare the effectiveness of metacarpophalangeal joint blocking splint versus relative motion extension splint for trigger finger. This will help us find out which one of the two splint designs is more effective in the management of trigger finger, thus improving treatment outcomes for patients with trigger finger.

Study Type

Interventional

Enrollment (Estimated)

30

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

  • New Zealand
    • Waikato
      • Hamilton, Waikato, New Zealand, 3204
        • Waikato 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Trigger finger patient

Exclusion Criteria:

  • Diabetes, non-English speaking

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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Splint M
Metacarpophalangeal joint blocking splint
Other: Splint
Comparison of splints for trigger finger
Experimental: Splint R
Relative motion extension splint
Other: Splint
Comparison of splints for trigger finger

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Green's classification for trigger finger
Time Frame: 12 weeks

Green's classification is an objective outcome measure. The therapist grades the triggering by observing the finger when the patient makes a full fist.

Grade I: Pain/history of catching Grade II: Demonstrable catching but can actively extend digit Grade III: Demonstrable locking, requiring passive extension Grade IV: Fixed flexion contracture

Lowest score is I; highest score is IV
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QuickDASH (Disability of Arm, Shoulder and Hand)
Time Frame: 12 weeks
The QuickDASH is a patient rated questionnaire that rates patient's ability to perform certain tasks as well as severity of symptoms. The best score is 0 (no difficulty) and the lowest score is 100 (severe difficulty).
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 12 weeks
The VAS is a patient rated outcome measure that enables the patient to rate the intensity of pain from 0 (no pain) to 10 (worse pain that can possibly be)
12 weeks

Collaborators and Investigators

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

Sponsor

Waikato Hospital

Investigators

  • Principal Investigator: Aarti Parekh, B.Physio, Waikato Hospital

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)

March 1, 2022

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

October 29, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WaikatoH

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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