Variable Perception of Cutaneous Stimulation

NCT ID: NCT03467685

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2018-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

VAD Off arm

This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration

Group Type: PLACEBO_COMPARATOR

Vibratory Anesthetic Device (VAD)

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Vibratory Anesthetic Device (VAD)

Intervention Type: DEVICE

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

Interventions

Vibratory Anesthetic Device (VAD)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients

Exclusion Criteria

• Patients less than 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Bryan Carroll

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Falk Medical Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31895257 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31513234 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Perception

Identifier Type: -

Identifier Source: org_study_id