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

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status and phase

Withdrawn
Phase 4

Conditions

Nail Diseases

Treatments

Drug: Ethyl chloride skin refrigerant spray
Device: External thermomechanical device without delivering cold and vibration stimuli
Device: External thermomechanical device delivering cold and vibration stimuli

Study type

Interventional

Funder types

Other

Identifiers

NCT04422795
20-03021647

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups, including a placebo group

External thermomechanical device delivering stimuli
Experimental group
Description:
The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.
Treatment:
Device: External thermomechanical device delivering cold and vibration stimuli
External thermomechanical device without delivering stimuli
Placebo Comparator group
Description:
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.
Treatment:
Device: External thermomechanical device without delivering cold and vibration stimuli
Nail injection with ethyl chloride skin refrigerant spray
Active Comparator group
Description:
Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion
Treatment:
Drug: Ethyl chloride skin refrigerant spray

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems