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

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Status and phase: Withdrawn; Phase 4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