Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting

Study Overview
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Brief Summary
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Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior to corticosteroid treatment alone.

Detailed Description
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Stenosing tenosynovitis, or more commonly trigger finger is a disease that can severely impact a patient's quality of life. Its incidence is said to be 28 persons per 100,000 annually. The disease is manifested in one or more fingers by finger locking in flexion or extension, leading to pain, discomfort and at times, loss of function. Patients frequently report having to snap their fingers back in position to alleviate symptoms. The pathophysiology relates to thickening of the flexor tendon sheath, which can impair tendon gliding within it. Although multiple treatment strategies are available, it is not entirely clear which treatment offers the best outcome, especially when the finger has not reached end stage locking. In general, corticosteroid injection into the tendon sheath is offered as the first line of treatment. Splinting alone has also been described as a reliable method treatment. However, Patel and Bassini indicated that steroid injection results in fewer recurrences than splinting alone. Surgery is typically reserved for recurrent triggering, cases refractory to injection, or digits locked in flexion. The effects of steroid injection followed by splinting however have not been reported in a comprehensive fashion. It may be that this form of treatment could result in a synergistic effect, which can offer a treatment modality superior to either injection or splinting alone. The purpose of this research study is to determine whether steroid injection followed by splinting is superior to injection alone.

Official Title
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Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial

Conditions
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Trigger Finger, Stenosing Tenosynovitis

Intervention / Treatment
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* Procedure: Corticosteroid injection + Trigger Splint+ Education and Home exercises
* Procedure: Corticosteroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trigger finger in one or more trigger fingers, in stages 2 to 5 (inclusive) Adult patient aged over 18 years. No prior treatment (splinting, injection or surgery) to the involved finger OR at least 1 year since last treatment of the involved finger. Exclusion Criteria: Exclude Trigger thumbs because they appear to be respond very favorably or unfavorably to treatment3 Exclude locked digits because surgery is indicated in these cases Pregnant patients Prisoners Patients with impaired decision-making capacity Patients that do not speak English and cannot fill in English language questionnaires.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corticosteroid injection<br>Standard corticosteroid injection. | Procedure: Corticosteroid injection<br>* Standard trigger finger corticosteroid injection.<br>|
| Experimental: Corticosteroid Injection and Trigger Splint<br>Corticosteroid Injection + Trigger Splint + Education + Home Exercises | Procedure: Corticosteroid injection + Trigger Splint+ Education and Home exercises<br>* Standard corticosteroid injection. Hand based, single digit trigger splint will be applied. Education and instructions about home exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage of finger triggering | Trigger Finger Stage: Normal Painful palpable nodule Triggering = Clicking = Catching Locking of finger in flexion or extension unlocked by active finger movement Locking of finger in flexion or extension unlocked by passive finger movement Locked finger in flexion or extension (Each stage may be painless or painful) | 1, 2, 4-6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failed treatment: surgical intervention required | Failed treatment OR Successful treatment | 1,2, 4-6, 12months | 
| Patient rated functional outcome | Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale | 1, 2, 4-6, 12months | 
| Pain | Visual Analog Scale | 1, 2, 4-6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trigger finger, orthotic intervention