Back to resultsComparison of Distraction Methods for Pain Relief of Trigger Finger Injection
Primary Purpose
Trigger Finger
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ethyl chloride spray
Pinching
No Site of Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Trigger Finger
Exclusion Criteria:
- Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
First Group
Second Group
Third Group
Fourth Group
Arm Description
Skin cooling with ethyl chloride spray will be used for 5 seconds prior to injection
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
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03445780
Brief Title
Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection
Official Title
Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No patients were enrolled; Senior author (Dr. Melamed) departed institution
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First Group
Arm Type
Experimental
Arm Description
Skin cooling with ethyl chloride spray will be used for 5 seconds prior to injection
Arm Title
Second Group
Arm Type
Experimental
Arm Description
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
Arm Title
Third Group
Arm Type
Experimental
Arm Description
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
Arm Title
Fourth Group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ethyl chloride spray
Other Intervention Name(s)
Bethamethasone
Intervention Description
Skin cooling with ethyl chloride spray 5 seconds prior to injection
Intervention Type
Procedure
Intervention Name(s)
Pinching
Intervention Description
Skin between the distal palmar crease and the palmo digital crease will be pinched for 5 seconds prior to injection
Intervention Type
Procedure
Intervention Name(s)
No Site of Procedure
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) Score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Trigger Finger
Exclusion Criteria:
Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eitan Melamed, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection
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