The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection

Nail Diseases Clinical Trial

Official title:

The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04422795
• Other study ID #: 20-03021647
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of a thermomechanical device delivering vibration and cold stimuli in lowering pain during intramatricial nail injections

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged 18 years or older

• Must understand and voluntarily sign an informed consent form

• All patients undergoing intramatricial nail injections at the Weill Cornell Medicine (WCM) Department of Dermatology

• Willingness to participate in the study

Exclusion Criteria:

• Inability of the patient to provide written informed consent for any reason

• Failure to have nail injection performed

• Likely inability to comply with the study protocol or cooperate fully with the research team

Related Conditions & MeSH terms

• Nail Diseases

Intervention

Device:
• External thermomechanical device delivering cold and vibration stimuli
the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings frozen and the vibration mechanism switched on, delivering vibration and cold stimuli to the area for 30 seconds before the intramatricial injection and until needle withdrawal
• External thermomechanical device without delivering cold and vibration stimuli
the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings at unfrozen and the vibration mechanism switched off, for 30 seconds before the intramatricial injection and until needle withdrawal

Drug:
• Ethyl chloride skin refrigerant spray
Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.	Pain will be self-reported, using the Wong-Baker FACES (0-10, with 0 representing absence of pain and 10 unbearable pain). Participants will be questioned about their level of pain in their nail prior to treatment, immediately after the needle insertion, during infiltration, and 5 seconds after needle extraction	prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction
Secondary	Number of participants with at least one adverse event	Adverse events will only include those that are determined to be related to the study device	Patients will be followed for 3 days following their nail injection