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

NCT ID: NCT04422795

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Nail Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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External thermomechanical device delivering stimuli

The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.

Group Type EXPERIMENTAL

External thermomechanical device delivering cold and vibration stimuli

Intervention Type 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 without delivering stimuli

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.

Group Type PLACEBO_COMPARATOR

External thermomechanical device without delivering cold and vibration stimuli

Intervention Type 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

Nail injection with ethyl chloride skin refrigerant spray

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

Group Type ACTIVE_COMPARATOR

Ethyl chloride skin refrigerant spray

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Ethyl chloride skin refrigerant spray

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shari R Lipner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20-03021647

Identifier Type: -

Identifier Source: org_study_id

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