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Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection

Sponsor
NYU Langone Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03445780
Collaborator
(none)
0
Enrollment
1
Location
4
Arms
10
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ethyl chloride spray
  • Procedure: Pinching
  • Procedure: No Site of Procedure
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: First Group

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

Drug: Ethyl chloride spray
Skin cooling with ethyl chloride spray 5 seconds prior to injection
Other Names:
  • Bethamethasone

    		•
    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
    Skin between the distal palmar crease and the palmo digital crease will be pinched for 5 seconds prior to injection
    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
    Skin cooling with ethyl chloride spray 5 seconds prior to injection
    Other Names:
  • Bethamethasone

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of Trigger Finger
    Exclusion Criteria:
    • Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University School of Medicine New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health

    Investigators

    • Principal Investigator: Eitan Melamed, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT03445780
    Other Study ID Numbers:
    • 17-01275
    First Posted:
    Feb 26, 2018
    Last Update Posted:
    Jan 27, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Trigger Finger Disorder
    Ethyl Chloride

    Study Results

    No Results Posted as of Jan 27, 2020