Variable Perception of Cutaneous Stimulation

NCT03467685 | Completed Results

• 1 other identifier: Perception
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Anesthesia, Local; Dermatology/Skin - Other

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Score

  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.

  Within 5 seconds of injection

Study Arms (2)

VAD Off arm

PLACEBO COMPARATOR

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)

VAD On arm

EXPERIMENTAL

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)

Interventions

Vibratory Anesthetic Device (VAD) DEVICE

This is a handheld \~10cm long tool, battery operated, which provides vibration at a rate of \~150 Hz

VAD Off arm; VAD On arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients

You may not qualify if:

• Patients less than 18 years of age

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Falk Medical Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Kazi R, Govas P, Slaugenhaupt RM, Carroll BT. Differential Analgesia From Vibratory Stimulation During Local Injection of Anesthetic: A Randomized Clinical Trial. Dermatol Surg. 2020 Oct;46(10):1286-1293. doi: 10.1097/DSS.0000000000002314.

  PMID: 31895257 DERIVED

• Govas P, Kazi R, Slaugenhaupt RM, Carroll BT. Effect of a Vibratory Anesthetic Device on Pain Anticipation and Subsequent Pain Perception Among Patients Undergoing Cutaneous Cancer Removal Surgery: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2019 Dec 1;21(6):480-486. doi: 10.1001/jamafacial.2019.0733.

  PMID: 31513234 DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Rashek Kazi
• Organization: UPMC Dermatology

kazir@upmc.edu

5167105208

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 16, 2018
• Study Start: June 19, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: September 18, 2020
• Results First Posted: September 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)