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

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

Study Overview

• Status: Withdrawn
• Conditions: Nail Diseases
• Intervention / Treatment: Device: External thermomechanical device delivering cold and vibration stimuli; Device: External thermomechanical device without delivering cold and vibration stimuli; Drug: Ethyl chloride skin refrigerant spray

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jose W Ricardo, MD; Phone Number: 9172937853; Email: jw.ricardo175@gmail.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
      • Contact: Shari R Lipner, MD, PhD; Phone Number: 646-962-3376; Email: shl9032@med.cornell.edu
      • Principal Investigator: Shari R Lipner, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: External thermomechanical device delivering 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.	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
Placebo Comparator: External thermomechanical device without delivering 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.	Device: 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
Active Comparator: Nail injection with ethyl chloride skin refrigerant spray; Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2024
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Nails; Intralesional injection; Thermomechanical stimulation
• Additional Relevant MeSH Terms: Skin Diseases; Nail Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ethyl Chloride
• Other Study ID Numbers: 20-03021647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes