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

Study Overview
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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

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

Conditions
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Nail Diseases

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: External thermomechanical device delivering stimuli<br>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<br>* 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<br>|
| Placebo Comparator: External thermomechanical device without delivering stimuli<br>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<br>* 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<br>|
| Active Comparator: Nail injection with ethyl chloride skin refrigerant spray<br>Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion | Drug: Ethyl chloride skin refrigerant spray<br>* Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with at least one adverse event | Adverse events will only include those that are determined to be related to the study device | Patients will be followed for 3 days following their nail injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nails, Thermomechanical stimulation, Intralesional injection