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

Phase 4

Withdrawn

• Conditions: Nail Diseases
• Interventions: Device: External thermomechanical device delivering cold and vibration stimuli; Drug: Ethyl chloride skin refrigerant spray; Device: External thermomechanical device without delivering cold and vibration stimuli

• Registration Number: NCT04422795
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07
• Study Start: 2024-02
• Primary Completion: 2025-02
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External thermomechanical device delivering stimuli	External thermomechanical device delivering cold and vibration stimuli	The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.
Nail injection with ethyl chloride skin refrigerant spray	Ethyl chloride skin refrigerant spray	Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion
External thermomechanical device without delivering stimuli	External thermomechanical device without delivering cold and vibration stimuli	The thermomechanical device is placed on the digit proximally to the injection site with the ice wings at room temperature (unfrozen) and the vibration mechanism switched off.

Primary Outcome Measures

Name	Time	Method
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.	prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction	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

Secondary Outcome Measures

Name	Time	Method
Number of participants with at least one adverse event	Patients will be followed for 3 days following their nail injection	Adverse events will only include those that are determined to be related to the study device

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States