Studies
| Study First Submitted Date | 2020-06-04 |
| Study First Posted Date | 2020-06-09 |
| Last Update Posted Date | 2023-04-07 |
| Start Month Year | February 2024 |
| Primary Completion Month Year | February 2025 |
| Verification Month Year | April 2023 |
| Verification Date | 2023-04-30 |
| Last Update Posted Date | 2023-04-07 |
Facilities
| Sequence: | 199425170 |
| Name | Weill Cornell Medicine |
| City | New York |
| State | New York |
| Zip | 10021 |
| Country | United States |
Browse Interventions
| Sequence: | 95740849 | Sequence: | 95740850 | Sequence: | 95740851 | Sequence: | 95740852 | Sequence: | 95740853 | Sequence: | 95740854 | Sequence: | 95740855 |
| Mesh Term | Ethyl Chloride | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
| Downcase Mesh Term | ethyl chloride | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52011924 |
| Name | Nail Diseases |
| Downcase Name | nail diseases |
Id Information
| Sequence: | 40033965 |
| Id Source | org_study_id |
| Id Value | 20-03021647 |
Countries
| Sequence: | 42430011 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55417731 | Sequence: | 55417732 | Sequence: | 55417733 |
| Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Active Comparator |
| Title | External thermomechanical device delivering stimuli | Title | External thermomechanical device without delivering stimuli | Title | Nail injection with ethyl chloride skin refrigerant spray |
| 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. | 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. | Description | Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion |
Interventions
| Sequence: | 52324301 | Sequence: | 52324302 | Sequence: | 52324303 |
| Intervention Type | Device | Intervention Type | Device | Intervention Type | Drug |
| Name | External thermomechanical device delivering cold and vibration stimuli | Name | External thermomechanical device without delivering cold and vibration stimuli | Name | Ethyl chloride skin refrigerant spray |
| Description | 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 | Description | 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 | Description | Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion |
Keywords
| Sequence: | 79613294 | Sequence: | 79613295 | Sequence: | 79613296 |
| Name | Nails | Name | Thermomechanical stimulation | Name | Intralesional injection |
| Downcase Name | nails | Downcase Name | thermomechanical stimulation | Downcase Name | intralesional injection |
Design Outcomes
| Sequence: | 176822459 | Sequence: | 176822460 |
| Outcome Type | primary | Outcome Type | secondary |
| Measure | 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. | Measure | Number of participants with at least one adverse event |
| Time Frame | prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction | Time Frame | Patients will be followed for 3 days following their nail injection |
| Description | 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 | Description | Adverse events will only include those that are determined to be related to the study device |
Browse Conditions
| Sequence: | 192855531 | Sequence: | 192855532 |
| Mesh Term | Nail Diseases | Mesh Term | Skin Diseases |
| Downcase Mesh Term | nail diseases | Downcase Mesh Term | skin diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48170506 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Weill Medical College of Cornell University |
Overall Officials
| Sequence: | 29193799 |
| Role | Principal Investigator |
| Name | Shari R Lipner, MD, PhD |
| Affiliation | Weill Medical College of Cornell University |
Design Group Interventions
| Sequence: | 67935692 | Sequence: | 67935693 | Sequence: | 67935694 |
| Design Group Id | 55417731 | Design Group Id | 55417732 | Design Group Id | 55417733 |
| Intervention Id | 52324301 | Intervention Id | 52324302 | Intervention Id | 52324303 |
Eligibilities
| Sequence: | 30671982 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254302523 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 1 |
Designs
| Sequence: | 30418753 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Supportive Care |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28785268 |
| Responsible Party Type | Sponsor |