Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection

Phase 1

Withdrawn

• Conditions: Trigger Finger
• Interventions: Drug: Ethyl chloride spray; Procedure: Pinching; Procedure: No Site of Procedure

• Registration Number: NCT03445780
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to evaluate the best distraction mechanism during trigger finger injection in the outpatient setting. Temporary discomfort from the needle prick is highly feared by patients and is often accompanied by significant acute pain and distress during routine corticosteroid injection in the orthopedic outpatient setting. This study aims to examine 4 different distraction methods and their efficacy in reducing perceived pain, which will be evaluate using the VAS (visual analog pain score.) The three distraction methods will be ethyl chloride spray, adjacent pinch, ethyl chloride spray and pinch, and "screen" or looking away method.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-26
• Study Start: 2019-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of Trigger Finger

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Exclusion Criteria

• Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
First Group	Ethyl chloride spray	Skin cooling with ethyl chloride spray will be used for 5 seconds prior to injection
Second Group	Pinching	The skin between the distal palmar crease and the palmo-digital crease and the palmo-digital crease will be pinched for 5 seconds prior to injection
Third Group	Pinching	Skin cooling with ethyl chloride spray will be used for 5 seconds prior to injection as well as a second pinch to the skin between the distal palmar crease and the palmo digital crease
Fourth Group	No Site of Procedure	Subjects will sit behind a screen with a small opening large enough to introduce the injection hand. They will not see any of the procedure.
Third Group	Ethyl chloride spray	Skin cooling with ethyl chloride spray will be used for 5 seconds prior to injection as well as a second pinch to the skin between the distal palmar crease and the palmo digital crease

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS) Score	1 Minute, 24 Hours	A 10-cm scale will be shown to the patients, and they will be asked to choose the proper number, with 1 representing no pain and 10 symbolizing the most pain imaginable

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States