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Completed

NCT Number: NCT05763017

Comparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for 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.

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Key information

Conditions

Trigger Finger Muscular Diseases Musculoskeletal Diseases Stenosing Tenosynovitis Tendinopathy Tendon Entrapment Trigger Finger Disorder

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sultan Haji Ahmad Shah

Temerluh, Pahang, 28000, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relative Motion Splint

Other

Six weeks relative motion splint wear.

Metacarpophalangeal Joint Blocking Splint

Other

Six weeks metacarpophalangeal joint blocking splint wear.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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".

  2. 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.

  3. 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.

  4. 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.

  5. 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".

  6. 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".

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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