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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03445780
Other study ID # 17-01275
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date June 2019
Est. completion date April 2020

Study information

Verified date January 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Diagnosis of Trigger Finger

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ethyl chloride spray
Skin cooling with ethyl chloride spray 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
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

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 Minute, 24 Hours
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