Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)
NCT ID: NCT06497764
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-04-30
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control (PRP Alone), then Intervention (PRP with VA)
Participants in this study arm will receive treatment with PRP alone first, then PRP+VA second. The first half of the scalp of each patient will be randomized to receive standard-of-care PRP alone. The second half of the scalp of each patient will receive VA via a device during the standard-of-care PRP treatment.
Vibrational Anesthesia (VA) Device
The half of the patient's scalp randomized to receive VA during PRP treatment will receive VA via the Buzzy bee-striped personal. The device is powered by two AAA batteries and is indicated for use for pain reduction. It uses the Melzack and Wall's Gait Control theory, which states that activation of non-nociceptive fibers can interfere with signals from pain fibers to inhibit overall sensation of pain.
PRP Treatment
PRP (a needle-related procedure) will be delivered per routine standard of care.
Intervention (PRP with VA), then Control (PRP Alone)
Participants in this study arm will receive treatment with PRP+VA first, then PRP alone second. The first half of the scalp of each patient will be randomized to receive VA via a device during the standard-of-care PRP treatment.. The second half of the scalp of each patient will receive standard-of-care PRP treatment alone.
Vibrational Anesthesia (VA) Device
The half of the patient's scalp randomized to receive VA during PRP treatment will receive VA via the Buzzy bee-striped personal. The device is powered by two AAA batteries and is indicated for use for pain reduction. It uses the Melzack and Wall's Gait Control theory, which states that activation of non-nociceptive fibers can interfere with signals from pain fibers to inhibit overall sensation of pain.
PRP Treatment
PRP (a needle-related procedure) will be delivered per routine standard of care.
Interventions
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Vibrational Anesthesia (VA) Device
The half of the patient's scalp randomized to receive VA during PRP treatment will receive VA via the Buzzy bee-striped personal. The device is powered by two AAA batteries and is indicated for use for pain reduction. It uses the Melzack and Wall's Gait Control theory, which states that activation of non-nociceptive fibers can interfere with signals from pain fibers to inhibit overall sensation of pain.
PRP Treatment
PRP (a needle-related procedure) will be delivered per routine standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to participate in study procedures.
* Able to provide consent.
Exclusion Criteria
* Patients unable to consent.
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Kristen Lo Sicco
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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24-00472
Identifier Type: -
Identifier Source: org_study_id
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