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WithdrawnNCT03445780Updated Jan 27, 2020

Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection

A Phase 1 interventional study of Ethyl chloride spray and Pinching in Trigger Finger, sponsored by NYU Langone Health. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by NYU Langone Health · Phase 1, Interventional, and Treatment

Why this study was withdrawn
No patients were enrolled; Senior author (Dr. Melamed) departed institution
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Trigger Finger
03

In context

Trigger Finger Disorder

93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.

Browse Trigger Finger Disorder studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.

Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of Trigger Finger

Exclusion criteria

Exclusion Criteria:

  • Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    First Group

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

    Drug: Ethyl chloride spray

  • Experimental
    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

    Procedure: Pinching

  • Experimental
    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

    Drug: Ethyl chloride spray · Procedure: Pinching

  • Experimental
    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.

    Procedure: No Site of Procedure

Interventions

  • Skin cooling with ethyl chloride spray 5 seconds prior to injection

    Also known as: Bethamethasone

  • ProcedurePinching

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

  • ProcedureNo 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

06

What researchers measure

Primary outcomes

  1. Change in Visual Analog Scale (VAS) Score

    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

    Time frame: 1 Minute, 24 Hours

07

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03445780
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Jun 2019 (estimated)
Primary completion
Apr 2020 (estimated)
Completion
Apr 2020 (estimated)
Last update
Jan 27, 2020

Study contacts

Eitan Melamed, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ethyl Chloride

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