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Variable Perception of Cutaneous Stimulation

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ClinicalTrials.gov Identifier: NCT03467685
Recruitment Status : Completed
First Posted : March 16, 2018
Results First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Bryan Carroll, University of Pittsburgh

Brief Summary:
Perception of cutaneous sensory stimulation shows a large range of variability across multiple populations. Understanding this variability is critical to medical practice as interpretation of discomfort and pain is critical to diagnosis and treatment. Further, procedural medicine involves inflicting pain on patients in the form of injection of local anesthetic. Our protocol aims to determine how patients differentially interpret the non-noxious stimulation of vibration and the differences in perceiving anesthestic injection after the vibratory stimulus. We will explore how this ranges across all patients treated in a dermatological surgery out-patient setting. The goal is to identify which variables, such as age, gender, medical history, influence how sensation is interpreted.

Condition or disease Intervention/treatment Phase
Pain, Acute Anesthesia, Local Dermatology/Skin - Other Device: Vibratory Anesthetic Device (VAD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Subjects will be randomly assigned into one of two groups:

Group 1: Vibratory anesthetic device (VAD) is in the OFF mode Group 2: VAD is in the ON mode

We will use a random number generator to place patients into one of the two groups.

Masking: Single (Participant)
Masking Description: Subjects will be asked to close their eyes prior to the vibration anesthetic device (VAD) being applied to their skin. Only the user will know whether the VAD will be on or off based on the result of a random number generator. This will prevent anticipatory changes on the subjects side. The subject will be aware of the intervention after the device is turned on or left in the off position.
Primary Purpose: Prevention
Official Title: Determining the Variable Factors in Cutaneous Perception of Vibratory Stimulation
Actual Study Start Date : June 19, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Arm Intervention/treatment
Placebo Comparator: VAD Off arm
This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration
Device: Vibratory Anesthetic Device (VAD)
This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz

Experimental: VAD On arm
This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration
Device: Vibratory Anesthetic Device (VAD)
This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz




Primary Outcome Measures :
  1. Numeric Rating Score [ Time Frame: Within 5 seconds of injection ]
    This is a tool used to measure the degree of pain perceived by the patient with application of the tool on their skin and following the injection of anesthetic which is part of the routine medical care of the patient. Score ranges from 0 to 10 with higher score indicating more pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients

Exclusion Criteria:

  • Patients less than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467685


Locations
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United States, Pennsylvania
Falk Medical Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Bryan Carroll, University of Pittsburgh:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bryan Carroll, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03467685    
Other Study ID Numbers: Perception
First Posted: March 16, 2018    Key Record Dates
Results First Posted: September 18, 2020
Last Update Posted: September 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data with other researchers. Data from this study may be used in future work.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs