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

Phase 4TerminatedNCT02421419

Kenneth Taylor, M.D.26 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Trigger Finger Disorder

Interventions

Dexamethasone Sodium PhosphateDRUG

adreno-cortical steroid anti-inflammatory drug

XylocaineDRUG

a local anesthetic agent

Sodium ChlorideDRUG

Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

VAS

Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.

Data from ClinicalTrials.gov

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