Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture

Study Overview
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Brief Summary
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This research is being done to compare pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Detailed Description
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This is a prospective, randomized study comparing pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Official Title
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Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture

Conditions
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Trigger Finger Disorder

Intervention / Treatment
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* Drug: Dexamethasone Sodium Phosphate
* Drug: Xylocaine
* Drug: Sodium Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-90 Male or female (non-pregnant) Clinically diagnosed trigger digit Subject is able to provide voluntary, written informed consent Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits. Exclusion Criteria: Age <18 or >90 Pregnant or lactating women Non-English speaking individuals Medication contradictions to lidocaine, corticosteroids and/or saline Prior injection or surgery on the affected finger Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome (CRPS) Open wound

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 alone (CS) Group<br>1 cc dexamethasone sodium phosphate (4mg/ml) injectable | Drug: Dexamethasone Sodium Phosphate<br>* adreno-cortical steroid anti-inflammatory drug<br>* Other names: Decadron phosphate;|
| Active Comparator: Corticosteroid/Lidocaine (CSL) Group<br>1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable | Drug: Dexamethasone Sodium Phosphate<br>* adreno-cortical steroid anti-inflammatory drug<br>* Other names: Decadron phosphate;Drug: Xylocaine<br>* a local anesthetic agent<br>* Other names: Lidocaine HCL;|
| Active Comparator: Corticosteroid/Saline (CSS) Group<br>1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline) | Drug: Dexamethasone Sodium Phosphate<br>* adreno-cortical steroid anti-inflammatory drug<br>* Other names: Decadron phosphate;Drug: Sodium Chloride<br>* Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst). | Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Triggering | Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected. | Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection | 
| Degree of Triggering | A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint. | Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey | 
| Number of Participants With Adverse Effects | Incidence of adverse effects | Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flexor tendon entrapment, snapping finger, trigger digits, trigger thumb