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

Study Overview
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Brief Summary
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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.

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

Conditions
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Trigger Finger, Stenosing Tenosynovitis

Intervention / Treatment
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* Other: Relative Motion Splint
* Other: Metacarpophalangeal Joint Blocking Splint


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relative Motion Splint<br>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<br>* Six weeks relative motion splint wear.<br>|
| Active Comparator: Metacarpophalangeal Joint Blocking Splint<br>In the metacarpophalangeal joint blocking splint, the metacarpophalangeal joint of the affected finger(s) positioned in 0°. | Other: Metacarpophalangeal Joint Blocking Splint<br>* Six weeks metacarpophalangeal joint blocking splint wear.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stages of Stenosing Tenosynovitis (SST) | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relative motion splint, metacarpophalangeal joint blocking splint