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Clinical Trials/NCT03445780
NCT03445780
Withdrawn
Phase 1

Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection

NYU Langone Health1 site in 1 countryJune 2019

Overview

Phase
Phase 1
Intervention
Ethyl chloride spray
Conditions
Trigger Finger
Sponsor
NYU Langone Health
Locations
1
Primary Endpoint
Change in Visual Analog Scale (VAS) Score
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2019
End Date
April 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Trigger Finger

Exclusion Criteria

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

Arms & Interventions

First Group

Skin cooling with ethyl chloride spray will be used for 5 seconds prior to injection

Intervention: Ethyl chloride spray

Second Group

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

Intervention: Pinching

Third Group

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

Intervention: Ethyl chloride spray

Third Group

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

Intervention: Pinching

Fourth Group

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.

Intervention: No Site of Procedure

Outcomes

Primary Outcomes

Change in Visual Analog Scale (VAS) Score

Time Frame: 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

Study Sites (1)

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