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

Primary Purpose

Nail Diseases

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
External thermomechanical device delivering cold and vibration stimuli
External thermomechanical device without delivering cold and vibration stimuli
Ethyl chloride skin refrigerant spray
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nail Diseases focused on measuring Nails, Thermomechanical stimulation, Intralesional injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

External thermomechanical device delivering stimuli

External thermomechanical device without delivering stimuli

Nail injection with ethyl chloride skin refrigerant spray

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2020
Last Updated
April 5, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04422795
Brief Title
The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
Official Title
The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Due to reallocation of resources, this study could not be initiated
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nail Diseases
Keywords
Nails, Thermomechanical stimulation, Intralesional injection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External thermomechanical device delivering stimuli
Arm Type
Experimental
Arm 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.
Arm Title
External thermomechanical device without delivering stimuli
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Nail injection with ethyl chloride skin refrigerant spray
Arm Type
Active Comparator
Arm Description
Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion
Intervention Type
Device
Intervention Name(s)
External thermomechanical device delivering cold and vibration stimuli
Intervention 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
Intervention Type
Device
Intervention Name(s)
External thermomechanical device without delivering cold and vibration stimuli
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Ethyl chloride skin refrigerant spray
Intervention Description
Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion
Primary Outcome Measure Information:
Title
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.
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
Time Frame
prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction
Secondary Outcome Measure Information:
Title
Number of participants with at least one adverse event
Description
Adverse events will only include those that are determined to be related to the study device
Time Frame
Patients will be followed for 3 days following their nail injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari R Lipner, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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