Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection

NCT ID: NCT03445780

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-30

Study Completion Date

2020-04-30

Brief Summary

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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

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Conditions

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Trigger Finger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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First Group

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

Group Type EXPERIMENTAL

Ethyl chloride spray

Intervention Type DRUG

Skin cooling with ethyl chloride spray 5 seconds prior to injection

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

Group Type EXPERIMENTAL

Pinching

Intervention Type PROCEDURE

Skin between the distal palmar crease and the palmo digital crease will be pinched for 5 seconds prior to injection

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

Group Type EXPERIMENTAL

Ethyl chloride spray

Intervention Type DRUG

Skin cooling with ethyl chloride spray 5 seconds prior to injection

Pinching

Intervention Type PROCEDURE

Skin between the distal palmar crease and the palmo digital crease will be pinched for 5 seconds prior to injection

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.

Group Type EXPERIMENTAL

No Site of Procedure

Intervention Type PROCEDURE

Subjects will sit behind a screen with a small opening large enough to introduce the injected hand. They will not see any of the procedure

Interventions

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Ethyl chloride spray

Skin cooling with ethyl chloride spray 5 seconds prior to injection

Intervention Type DRUG

Pinching

Skin between the distal palmar crease and the palmo digital crease will be pinched for 5 seconds prior to injection

Intervention Type PROCEDURE

No Site of Procedure

Subjects will sit behind a screen with a small opening large enough to introduce the injected hand. They will not see any of the procedure

Intervention Type PROCEDURE

Other Intervention Names

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Bethamethasone

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Trigger Finger

Exclusion Criteria

* Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eitan Melamed, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-01275

Identifier Type: -

Identifier Source: org_study_id

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