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Due to reallocation of resources, this study could not be initiated
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shari R Lipner, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
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| 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 |
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| 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 |
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| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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