Trial Outcomes & Findings for Variable Perception of Cutaneous Stimulation (NCT NCT03467685)

Last Updated: 2020-09-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

101 participants

Primary outcome timeframe

Within 5 seconds of injection

Results posted on

2020-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	VAD Off Arm 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	VAD On Arm 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
Overall Study STARTED	52	49
Overall Study COMPLETED	52	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VAD Off Arm n=52 Participants 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	VAD On Arm n=49 Participants 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 n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=52 Participants	0 Participants n=49 Participants	0 Participants n=101 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=52 Participants	28 Participants n=49 Participants	52 Participants n=101 Participants
Age, Categorical >=65 years	28 Participants n=52 Participants	21 Participants n=49 Participants	49 Participants n=101 Participants
Age, Continuous	66 years STANDARD_DEVIATION 1.1 • n=52 Participants	66 years STANDARD_DEVIATION 1.1 • n=49 Participants	66 years STANDARD_DEVIATION 1.1 • n=101 Participants
Sex: Female, Male Female	20 Participants n=52 Participants	17 Participants n=49 Participants	37 Participants n=101 Participants
Sex: Female, Male Male	32 Participants n=52 Participants	32 Participants n=49 Participants	64 Participants n=101 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	52 participants n=52 Participants	49 participants n=49 Participants	101 participants n=101 Participants
Location of treatment on body Head and Neck	38 Participants n=52 Participants	34 Participants n=49 Participants	72 Participants n=101 Participants
Location of treatment on body Trunk Extremities	14 Participants n=52 Participants	15 Participants n=49 Participants	29 Participants n=101 Participants

PRIMARY outcome

Timeframe: Within 5 seconds of injection

Outcome measures

Outcome measures
Measure	VAD Off Arm n=52 Participants 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	VAD On Arm n=49 Participants 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
Numeric Rating Score	2.0 score on a scale Standard Deviation 0.4	1.2 score on a scale Standard Deviation 0.2

Adverse Events

VAD Off Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VAD On Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rashek Kazi

UPMC Dermatology

Phone: 5167105208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place