Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection

NCT03445780 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 17-01275
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigger Finger

Outcome Measures

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

  1 Minute, 24 Hours

Study Arms (4)

First Group

EXPERIMENTAL

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

Drug: Ethyl chloride spray

Second Group

EXPERIMENTAL

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

Third Group

EXPERIMENTAL

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

Fourth Group

EXPERIMENTAL

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

Ethyl chloride spray DRUG

Skin cooling with ethyl chloride spray 5 seconds prior to injection

Also known as: Bethamethasone

First Group; Third Group

Pinching PROCEDURE

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

Second Group; Third Group

No Site of Procedure 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

Fourth Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Trigger Finger

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Eitan Melamed, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 26, 2018
• Study Start: June 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (1)