Nail DiseasesPhase 4NCT04422795
The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
A Phase 4 study testing External thermomechanical device delivering cold and vibration stimuli, External thermomechanical device without delivering cold and vibration stimuli and Ethyl chloride skin refrigerant spray in people with Nail Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Diseases
- What is being tested?
- External thermomechanical device delivering cold and vibration stimuli, External thermomechanical device without delivering cold and vibration stimuli and Ethyl chloride skin refrigerant spray
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2024to Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Nail Diseases
- Being tested
- External thermomechanical device delivering cold and vibration stimuli, External thermomechanical device without delivering cold and vibration stimuli, Ethyl chloride skin refrigerant spray
- Keywords
- Nails, Thermomechanical stimulation, Intralesional injection
- Medical subject headings
- Nail Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External thermomechanical device delivering cold and vibration stimuliDevice
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
External thermomechanical device without delivering cold and vibration stimuliDevice
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
Ethyl chloride skin refrigerant sprayDrug
Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: External thermomechanical device delivering cold and vibration stimuli |
| 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. Receives: Device: External thermomechanical device without delivering cold and vibration stimuli |
| 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 Receives: Drug: Ethyl chloride skin refrigerant spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction
Secondary outcomes (1)
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
Measured: Patients will be followed for 3 days following their nail injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: Due to reallocation of resources, this study could not be initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail DiseasesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari R Lipner, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422795
- Sponsor's protocol ID
- 20-03021647
- Status last verified
- Apr 2023
- First submitted
- 4 Jun 2020
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
- ClinicalTrials.gov ID
- NCT04422795
- Acronym / sponsor ID
- 20-03021647
- Conditions
- Nail Diseases
- Keywords
- Nails, Thermomechanical stimulation, Intralesional injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to reallocation of resources, this study could not be initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| External thermomechanical device delivering stimuli | Experimental | Device: External thermomechanical device delivering cold and vibration stimuliThe thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on. |
| External thermomechanical device without delivering stimuli | Placebo comparator | Device: External thermomechanical device without delivering cold and vibration stimuliThe 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. |
| Nail injection with ethyl chloride skin refrigerant spray | Active comparator | Drug: Ethyl chloride skin refrigerant sprayEthyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External thermomechanical device delivering cold and vibration stimulithe 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 | Device | External thermomechanical device delivering stimuli |
| External thermomechanical device without delivering cold and vibration stimulithe 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 | Device | External thermomechanical device without delivering stimuli |
| Ethyl chloride skin refrigerant sprayEthyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion | Drug | Nail injection with ethyl chloride skin refrigerant spray |
Primary outcome
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.
Time frame: prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction
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
1 secondary outcome
Number of participants with at least one adverse event
Time frame: Patients will be followed for 3 days following their nail injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari R Lipner, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing External thermomechanical device delivering cold and vibration stimuli, External thermomechanical device without delivering cold and vibration stimuli and Ethyl chloride skin refrigerant spray in people with Nail Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.