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

NCT04422795 | Withdrawn Phase 4 DMC FDA Device

• 1 other identifier: 20-03021647
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nails; Thermomechanical stimulation; Intralesional injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with at least one adverse event

  Patients will be followed for 3 days following their nail injection

Study Arms (3)

External thermomechanical device delivering stimuli

EXPERIMENTAL

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

External thermomechanical device without delivering stimuli

PLACEBO COMPARATOR

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

Nail injection with ethyl chloride skin refrigerant spray

ACTIVE COMPARATOR

Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion

Drug: Ethyl chloride skin refrigerant spray

Interventions

External thermomechanical device delivering cold and vibration stimuli DEVICE

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

External thermomechanical device delivering stimuli

External thermomechanical device without delivering cold and vibration stimuli DEVICE

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

External thermomechanical device without delivering stimuli

Ethyl chloride skin refrigerant spray DRUG

Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion

Nail injection with ethyl chloride skin refrigerant spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Nail Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shari R Lipner, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)