NCT04422795

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-02-01
• Completion: 2025-07-01
• First posted: 2020-06-09
• Last updated: 2023-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study