Effectiveness of Cortisone Injection and Splinting for Trigger Finger

Study Overview
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Brief Summary
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Trigger finger has a prevalence rate of up to 3%. There are many approaches available to manage this condition. While corticosteroid injection is widely accepted as the most common first-line treatment, its superiority over splint treatment has not been established. This study aims to test the effectiveness of cortisone injections, splint and cortisone+splint to resolve symptoms.

Detailed Description
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BACKGROUND: Multiple approaches, such as nonsteroidal anti-inflammatory medication (NSAIDs), splinting, percutaneous surgery, and open surgery, are available for managing trigger finger, blind corticosteroid injection has been widely accepted as the most common first-line treatment (Castellanos 2015). Splinting is helpful in reducing symptoms, is relatively inexpensive and has a low risk of complications, however, no concrete evidence exists to support the role of splinting in patients presenting with trigger finger (Tarbhai 2012). Surgical intervention is the most effective treatment; however, it is associated with higher risks and loss of time from work (Nimigan 2006). Corticosteroid injection is considered the most effective treatment to resolve symptoms in nondiabetic patients, as the success rate is slightly lower in patients with diabetes (Nimigan 2006). Although there are few studies suggesting effectiveness of cortisone injections and splinting for patients with trigger finger. There is lack of consensus on whether cortisone injections and splinting are effective on their own or in combination to resolve patient symptoms in the long term. OBJECTIVE: The objective is to prospectively compare the effectiveness of cortisone injections, splint and cortisone+splint for complete resolution of symptoms for the entirety of the follow-up period. STUDY DESIGN AND METHODOLOGY: This is a randomized controlled trial. On receipt of consent, the subjects will be screened for eligibility criteria and informed about the study by their surgeon or their delegate, Katrina Munro who is a research assistant working on this project. They will be informed that if they choose to participate, they will be randomized to receive either a splint, corticosteroid injection or both. Side effects will be explained. In keeping with standard ethical procedures, patients will be informed about confidentiality, that their care will not be affected by their choice, and their rights to withdraw consent at any time. Upon receiving verbal consent, patients will sign the consent form approved by the institutional/ ethics review board. Once a patient has consented, block randomization will occur according to the following stratification variables: A.Severity Grade 1 (pain/history of catching) and Grade 2 (demonstrable catching, can actively extend) Grade 3 (demonstrable locking, requiring passive extension) B. Diabetes (y/n) DATA ANALYSIS: Statistical Package for Social Sciences for Windows software (SPSS version 23, IBM SPSS Inc., Chicago, Ill., USA) for Windows (Microsoft) will be used for statistical analyses. Variables will be expressed as mean and range or mean ± SD, as appropriate. Univariate analysis will be used to compare clinical, and demographic data between study groups, including independent t-test for continuous variables and chi square test for categorical variables. General linear models with repeated measures of ANOVA and mixed model ANOVA will be used to examine the change in outcomes within and between the participant groups respectively. Non-parametric tests will be employed when applicable. Logistic and linear multivariate regression analysis will be used to examine binary and continuous outcome variables respectively, controlling for confounding variables.

Official Title
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Effectiveness of Cortisone Injection and Splinting for Trigger Finger: A Prospective Randomized Controlled Trial

Conditions
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Trigger Finger

Intervention / Treatment
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* Other: Splint
* Drug: Betamethasone
* Combination Product: Splint + Cortico-steroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally mature adults Symptom duration of at least 3 months Diagnosis of trigger finger: based on history of triggering and physical examination (pain over the flexor tendon, tenderness or nodule over the A1 pulley, stiffness, and reproducible locking or triggering). Green's Grade 1-3 (Green's Classification to Grade the Severity of Trigger Finger) Exclusion Criteria: Congenital trigger thumb Green's Grade 4 (fixed flexion contracture) Previous treatment for trigger finger (injection or surgery) Allergy to cortisone Multiple digits (>2 digits)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Splint alone<br> | Other: Splint<br>* Custom made splint<br>|
| Experimental: Cortico-steroid alone<br> | Drug: Betamethasone<br>* Corticosteroid Injection Brand name of the drug: Celestone Soluspan Dosage: 6 mg/ml<br>|
| Experimental: Splint and cortico-steroid combined<br> | Combination Product: Splint + Cortico-steroid injection<br>* Splint + Cortico-steroid injection given in combination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of symptoms | complete relief/partial relief/no relief | 6 week | 
| Resolution of symptoms | complete relief/partial relief/no relief | 3 month | 
| Resolution of symptoms | complete relief/partial relief/no relief | 6 month | 
| Resolution of symptoms | complete relief/partial relief/no relief | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' experiences with the splint - Compliance | 1 poor 2 fair 3 good 4 very good 5 excellent | 6 week | 
| Patients' experiences with the splint - Compliance | 1 poor 2 fair 3 good 4 very good 5 excellent | 3 month | 
| Patients' experiences with the splint - Compliance | 1 poor 2 fair 3 good 4 very good 5 excellent | 6 month | 
| Patients' experiences with the splint - Compliance | 1 poor 2 fair 3 good 4 very good 5 excellent | 1 year | 
| Patients' experiences with the splint - Comfort | 1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable | 6 week | 
| Patients' experiences with the splint - Comfort | 1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable | 3 month | 
| Patients' experiences with the splint - Comfort | 1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable | 6 month | 
| Patients' experiences with the splint - Comfort | 1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable | 1 year | 
| Patients' experiences with the splint - Ease of use | 1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use | 6 week | 
| Patients' experiences with the splint - Ease of use | 1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use | 3 month | 
| Patients' experiences with the splint - Ease of use | 1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use | 6 month | 
| Patients' experiences with the splint - Ease of use | 1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use | 1 year | 
| Pain (Visual analogue scale) | on a scale ranging from No pain to Pain as bad as it could possibly be) | 6 week | 
| Pain (Visual analogue scale) | on a scale ranging from No pain to Pain as bad as it could possibly be) | 3 month | 
| Pain (Visual analogue scale) | on a scale ranging from No pain to Pain as bad as it could possibly be) | 6 month | 
| Pain (Visual analogue scale) | on a scale ranging from No pain to Pain as bad as it could possibly be) | 1 year | 
| Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts | Number of times | 6 weeks | 
| Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts | Number of times | 3 month | 
| Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts | Number of times | 6 month | 
| Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts | Number of times | 1 year | 
| Incidence of Triggering: Severity (on Greens Grading Criteria) | Grade 1: Pain/history of catching Grade 2: Demonstrate catching, but can actively extend the digit Grade 3: Demonstrate locking, requiring passive extension Grade 4: Fixed flexion contracture | 6 week | 
| Incidence of Triggering: Severity (on Greens Grading Criteria) | Grade 1: Pain/history of catching Grade 2: Demonstrate catching, but can actively extend the digit Grade 3: Demonstrate locking, requiring passive extension Grade 4: Fixed flexion contracture | 3 month | 
| Incidence of Triggering: Severity (on Greens Grading Criteria) | Grade 1: Pain/history of catching Grade 2: Demonstrate catching, but can actively extend the digit Grade 3: Demonstrate locking, requiring passive extension Grade 4: Fixed flexion contracture | 6 month | 
| Incidence of Triggering: Severity (on Greens Grading Criteria) | Grade 1: Pain/history of catching Grade 2: Demonstrate catching, but can actively extend the digit Grade 3: Demonstrate locking, requiring passive extension Grade 4: Fixed flexion contracture | 1 year | 
| Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire | on a scale of 0 (good) to 100 (poor) | 6 week | 
| Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire | on a scale of 0 (good) to 100 (poor) | 3 month | 
| Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire | on a scale of 0 (good) to 100 (poor) | 6 month | 
| Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire | on a scale of 0 (good) to 100 (poor) | 1 year | 
| Grip Strength (Affected hand) | Kilogram (Kg) | 6 week | 
| Grip Strength (Affected hand) | Kilogram (Kg) | 3 month | 
| Grip Strength (Affected hand) | Kilogram (Kg) | 6 month | 
| Grip Strength (Affected hand) | Kilogram (Kg) | 1 year | 
| Grip Strength (Un-affected hand) | Kilogram (Kg) | 6 weeks | 
| Grip Strength (Un-affected hand) | Kilogram (Kg) | 3 month | 
| Grip Strength (Un-affected hand) | Kilogram (Kg) | 6 month | 
| Grip Strength (Un-affected hand) | Kilogram (Kg) | 1 year | 
| Range of motion (Extensor lag) | degrees | 6 weeks | 
| Range of motion (Extensor lag) | degrees | 3 month | 
| Range of motion (Extensor lag) | degrees | 6 month | 
| Range of motion (Extensor lag) | degrees | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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splinting, steroid, cortisone, trigger digit