Comparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for Trigger Finger

March 27, 2024 updated by: National University of Malaysia

A Randomized Comparative Trial of Relative Motion Splint Versus Metacarpophalangeal Joint Blocking Splint in the Management of Trigger Finger

The purpose of this study is to compare the effectiveness of relative motion splint and metacarpophalangeal joint blocking splints in terms of sign and symptoms, hand function, occupational performance, and perception of splint wearability (comfort and satisfaction) after six weeks of TF management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

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 Contact

Study Locations

  • Malaysia
    • Pahang
      • Temerluh, Pahang, Malaysia, 28000
        • Recruiting
        • Hospital Sultan Haji Ahmad Shah
        • Contact:

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • single or multiple trigger finger
  • unilateral or bilateral trigger finger
  • neutral metacarpophalangeal joint position can be attained during passive isolated metacarpophalangeal joint extension of the affected finger

Exclusion Criteria:

  • trigger thumb
  • steroid injection of the affected finger within last six months
  • A1 pulley release of the affected finger.
  • history of fracture, tendon injury, nerve injury, Dupuytren's contracture, and other soft tissue injuries of the affected finger or adjacent fingers.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relative Motion Splint
In the relative motion splint, the metacarpophalangeal joint of the affected finger(s) positioned in approximately 20°-25° more extension/flexion than metacarpophalangeal joint of the adjacent fingers.
Other: Relative Motion Splint
Six weeks relative motion splint wear.
Active Comparator: Metacarpophalangeal Joint Blocking Splint
In the metacarpophalangeal joint blocking splint, the metacarpophalangeal joint of the affected finger(s) positioned in 0°.
Other: Metacarpophalangeal Joint Blocking Splint
Six weeks metacarpophalangeal joint blocking splint wear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stages of Stenosing Tenosynovitis (SST)
Time Frame: Baseline, 6 weeks after splint wear
SST is a grading system that divides trigger finger into six stages. Stage 1 is normal; Stage 2 is uneven finger movement; Stage 3 is triggering or clicking or catching; Stage 4 is locking of finger in flexion or extension, which can be unlocked by active finger movement; Stage 5 is locking of finger in flexion or extension, which requires application of passive force to unlock; and Stage 6 is locked finger in flexion or extension
Baseline, 6 weeks after splint wear

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) for pain
Time Frame: Baseline, 6 weeks after splint wear
The left end of the VAS labelled as "no pain" and the right end labelled as "extreme pain".
Baseline, 6 weeks after splint wear
Number of triggering events in ten active fists
Time Frame: Baseline, 6 weeks after splint wear
The number of triggering events (0 - 10) can be obtained by asking the patient to make 10 active full fists.
Baseline, 6 weeks after splint wear
Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Time Frame: Baseline, 6 weeks after splint wear
DASH is a 30-item, self-report questionnaire that range from 0-100 score, with higher scores represent more severe disability or poorer hand function.
Baseline, 6 weeks after splint wear
Canadian Occupational Performance Measure (COPM)
Time Frame: Baseline, 6 weeks after splint wear
COPM is a interview-based assessment tool for measuring occupational performance. The importance, satisfaction, and performance of an activity are rated using a 10-point rating scale.
Baseline, 6 weeks after splint wear
Visual Analog Scale (VAS) for splint comfort
Time Frame: Baseline, 3 and 6 weeks after splint wear
The left end of the VAS labelled as "not at all comfortable' and the right end labelled as "extremely comfortable".
Baseline, 3 and 6 weeks after splint wear
Visual Analog Scale (VAS) for splint satisfaction
Time Frame: Baseline, 3 and 6 weeks after splint wear
The left end of the VAS labelled as "not at all satisfied" and the right end labelled as "extremely satisfied".
Baseline, 3 and 6 weeks after splint wear

Collaborators and Investigators

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

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Siaw Chui Chai, PhD (OT), Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab)

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)

June 28, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEP-2022-319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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