Conservative Treatment of Trigger Finger

Study Overview
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Brief Summary
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This study is to analyze the effectiveness of a nighttime extension orthosis after receiving a cortisone injection for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.

Detailed Description
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The purpose of the research is to analyze the effectiveness of a proximal interphalangeal joint (PIPJ) extension night orthosis status-post cortisone injection of the first annular pulley for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes (Quick Dash score) compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.

Official Title
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Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial

Conditions
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Hand Injuries, Trigger Finger

Intervention / Treatment
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* Device: Oval-8 ® Orthosis
* Other: Cortisone injection only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals 18 years old or older are included Patients with trigger finger, aka stenosing flexor tenosynovitis Status post receiving cortisone injection of the affected digit(s) Exclusion Criteria: Any records flagged with break the glass or research opt out Patients with rheumatoid arthritis Patients with a history of traumatic injury to the hand Cognitive or behavioral problems which would preclude informed consent Unable to speak and understand English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Interventional Model Description: The primary objective of this study is to analyze the effectiveness of a nighttime PIP joint extension orthosis to improve pain and restore functional outcomes in TF and comparing two groups of participants with TF, one group receiving a cortisone injection only and the experimental group receiving the nighttime orthosis after cortisone injection using the QuickDASH.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis<br>The experimental group will consist of receiving a PIP joint on the day they receive their cortisone injection. The Oval-8 ® will be issued to the subject by an Occupational Therapist to ensure correct fit and comfort as well as given written instructions for night use. The orthosis will be worn at night for 6-week duration. Participants will have 1 follow up phone call or email at the 6-week mark and then 1 follow up phone call or email at the 12 week mark by a member of the research team from the time they received their cortisone injection where the time for resolution of trigger finger symptoms, VAS (Visual Analogue Scale), subjective questionnaire and QuickDASH scores will all be recorded in their medical research file. | Device: Oval-8 ® Orthosis<br>* The experimental group will consist of receiving a PIP joint on the day they receive their cortisone injection. The Oval-8 ® will be issued to the subject by an Occupational Therapist to ensure correct fit and comfort as well as given written instructions for night use. The orthosis will be worn at night for 6-week duration. Participants will have 1 follow up phone call or email at the 6-week mark and then 1 follow up phone call or email at the 12 week mark by a member of the research team from the time they received their cortisone injection where the time for resolution of trigger finger symptoms, VAS (Visual Analogue Scale), subjective questionnaire and QuickDASH scores will all be recorded in their medical research file.<br>* Other names: Cortisone Injection;|
| Active Comparator: Control Group-No Orthosis<br>The control group will be identical to the experimental group except without the use of a nighttime orthosis. Participants will have 1 follow up phone call or email at the 6-week mark and then 1 follow up phone call or email at the 12 week mark by a member of the research team from the time they received their cortisone injection where the time for resolution of trigger finger symptoms, VAS (Visual Analogue Scale), subjective questionnaire and QuickDASH scores will all be recorded in their medical research file. | Other: Cortisone injection only<br>* The control group will receive a cortisone injection and be instructed to move their fingers normally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Trigger Finger Symptoms | Questionnaire used to determine resolution of Trigger Finger Symptoms | 6 Weeks | 
| Resolution of Trigger Finger Symptoms | Questionnaire used to determine resolution of Trigger Finger Symptoms | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Visual Analogue Scale for Pain (0 pain free to 10 severe pain) | 6 weeks | 
| Change in Pain | Visual Analogue Scale for Pain (0 pain free to 10 severe pain) | 12 weeks | 
| Change in Perception of Function | QuickDash scores (0% no functional limitations to 100% disabled) | 12 weeks |