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

Phase 4

Terminated

• Conditions: Trigger Finger Disorder
• Interventions: Drug: Dexamethasone Sodium Phosphate; Drug: Xylocaine; Drug: Sodium Chloride

• Registration Number: NCT02421419
• Lead Sponsor: Kenneth Taylor, M.D.

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-20
• Study Start: 2015-06
• Primary Completion: 2017-01-25
• Study Completion: 2017-01-25
• Results First Submitted: 2017-07-10
• Results First Submitted QC: 2017-12-20
• Results First Posted: 2018-01-23
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid/Lidocaine (CSL) Group	Xylocaine	1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Corticosteroid/Lidocaine (CSL) Group	Dexamethasone Sodium Phosphate	1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Corticosteroid alone (CS) Group	Dexamethasone Sodium Phosphate	1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Corticosteroid/Saline (CSS) Group	Dexamethasone Sodium Phosphate	1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Corticosteroid/Saline (CSS) Group	Sodium Chloride	1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Effects	Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.	Incidence of adverse effects
Presence of Triggering	Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection	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.
Degree of Triggering	Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey	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.

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States