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

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