MedTrace Logo

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

NCT04422795 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-04-07

No results posted yet for this study

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

Conditions

  • Nail Diseases

Interventions

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

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

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

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Shari R Lipner, MD, PhD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-02-28
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04422795 on ClinicalTrials.gov