Pain, AcuteNCT03467685
Variable Perception of Cutaneous Stimulation
A study testing Vibratory Anesthetic Device (VAD) in people with Pain, Acute and Anesthesia, Local, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Anesthesia, Local, Dermatology/Skin - Other
- What is being tested?
- Vibratory Anesthetic Device (VAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients
Who cannot join
- Patients less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Variable Factors in Cutaneous Perception of Vibratory Stimulation
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
- Being tested
- Vibratory Anesthetic Device (VAD)
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibratory Anesthetic Device (VAD)Device
This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Vibratory Anesthetic Device (VAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 5 seconds of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start19 Jun 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Carroll, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467685
- Sponsor's protocol ID
- Perception
- Status last verified
- Aug 2020
- First submitted
- 9 Mar 2018
- Last updated
- 18 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data with other researchers. Data from this study may be used in future work.
Publications
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.
PubMed 31895257Govas 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.
PubMed 31513234
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Variable Factors in Cutaneous Perception of Vibratory Stimulation
- ClinicalTrials.gov ID
- NCT03467685
- Acronym / sponsor ID
- Perception
- Conditions
- Pain, Acute, Anesthesia, Local, Dermatology/Skin - Other
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Posted 18 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VAD Off arm | Placebo comparator | Device: Vibratory Anesthetic Device (VAD)This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration |
| VAD On arm | Experimental | Device: Vibratory Anesthetic Device (VAD)This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients
Key exclusion criteria (1 listed)
- Patients less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibratory Anesthetic Device (VAD)This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz | Device | VAD Off arm, VAD On arm |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31895257Kazi 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.
- Derived from this study: PubMed 31513234Govas 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.
- Individual participant dataSharing planned: No. No plan to share data with other researchers. Data from this study may be used in future work.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibratory Anesthetic Device (VAD) in people with Pain, Acute and Anesthesia, Local, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Score (time frame: Within 5 seconds of injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03467685, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.