Variable Perception of Cutaneous Stimulation

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT03467685
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 29.8

Study Details

Study Description

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)	N/A

Study Design

• Study Type: Interventional
• 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.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: Jun 19, 2018
• Actual Primary Completion Date: Sep 30, 2018
• Actual Study Completion Date: Sep 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Numeric Rating Score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All patients

Exclusion Criteria:

• Patients less than 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Falk Medical Clinic	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - May 21, 2018

More Information

Publications

None provided.

• Responsible Party: Bryan Carroll, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03467685
• Other Study ID Numbers: Perception
• First Posted: Mar 16, 2018
• Last Update Posted: Sep 18, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Pain; Anesthetics

Study Results

Participant Flow

Arm/Group Title	VAD Off Arm	VAD On Arm
Arm/Group Description	This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz	This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz
Period Title: Overall Study
STARTED	52	49
COMPLETED	52	49
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	VAD Off Arm	VAD On Arm	Total
Arm/Group Description	This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz	This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz	Total of all reporting groups
Overall Participants	52	49	101
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	24 46.2%	28 57.1%	52 51.5%
>=65 years	28 53.8%	21 42.9%	49 48.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (1.1)	66 (1.1)	66 (1.1)
Sex: Female, Male (Count of Participants)
Female	20 38.5%	17 34.7%	37 36.6%
Male	32 61.5%	32 65.3%	64 63.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	52 100%	49 100%	101 100%
Location of treatment on body (Count of Participants)
Head and Neck	38 73.1%	34 69.4%	72 71.3%
Trunk Extremities	14 26.9%	15 30.6%	29 28.7%

Outcome Measures

1. Primary Outcome

Title	Numeric Rating Score
Description	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.
Time Frame	Within 5 seconds of injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VAD Off Arm	VAD On Arm
Arm/Group Description	This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz	This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz
Measure Participants	52	49
Mean (Standard Deviation) [score on a scale]	2.0 (0.4)	1.2 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VAD Off Arm, VAD On Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	The definition of adverse events does not differ from that of clinicaltrials.gov.
Arm/Group Title	VAD Off Arm		VAD On Arm
Arm/Group Description	This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz		This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz
All Cause Mortality
	VAD Off Arm		VAD On Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/49 (0%)
Serious Adverse Events
	VAD Off Arm		VAD On Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	VAD Off Arm		VAD On Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/49 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.