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Behavioural Intervention

External thermomechanical device delivering cold and vibration stimuli for Nail Diseases

Phase 4

Waitlist Available

Led By Shari R Lipner, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction

Awards & highlights

Study Summary

This trial will test whether a device that delivers vibration and cold stimuli can lower pain during intramatricial nail injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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.

Secondary outcome measures

Number of participants with at least one adverse event

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: External thermomechanical device delivering stimuliExperimental Treatment1 Intervention

The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.

Group II: Nail injection with ethyl chloride skin refrigerant sprayActive Control1 Intervention

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

Group III: External thermomechanical device without delivering stimuliPlacebo Group1 Intervention

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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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,552 Total Patients Enrolled

4 Trials studying Nail Diseases

41 Patients Enrolled for Nail Diseases

Shari R Lipner, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University

2 Previous Clinical Trials

10 Total Patients Enrolled

2 Trials studying Nail Diseases

10 Patients Enrolled for Nail Diseases

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA certified a mechanized, external device that offers cold and vibrational therapy?

"Our team believes that the External thermomechanical device delivering cold and vibration stimuli is highly safe, thus bestowing it a rating of 3. This is because this treatment has already been approved after passing through Phase 4 clinical trials."

Answered by AI

Are there any available spots for participants in this research program?

"At present, this study is not accepting new candidates. The trial was first made available on February 1st 2024 and last updated April 27th 2022. Should you be interested in other studies, three trials for nail diseases are actively enrolling participants as well as one involving an External thermomechanical device delivering cold and vibration stimuli."

Answered by AI

How many participants are involved in this trial?

"Currently, this trial is not in a recruitment phase. It was initially posted on February 1st 2024 and the last update to its status occurred on April 27th 2022. However, there are four other studies actively searching for participants: three pertaining to nail diseases and one involving an external thermomechanical device delivering cold and vibration stimuli."

Answered by AI

Are there any additional research projects that have evaluated the efficacy of an External thermomechanical device providing cold and vibration stimuli?

"Presently, there is one active clinical trial centered around External thermomechanical device delivering cold and vibration stimuli. This investigation is not located within Phase 3 of the medical research process yet. Despite this fact, most studies are positioned in New york City with an additional location conducting pertinent trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04422795.