Trials / Withdrawn
WithdrawnNCT06497764
Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)
A Pilot, Randomized, Non-blinded, Single-center Study of the Efficacy of a Vibrational Anesthesia (VA) Device on Reducing Pain During Platelet Rich Plasma (PRP) Scalp Treatment for Alopecia
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice. The investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (VA) via a device and the other half will not. Approximately 100 unique patients will be recruited (there will only be one study group). During the standard of care platelet rich plasma (PRP) procedure, a REDCap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale (VAS). A simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| PROCEDURE | PRP Treatment | PRP (a needle-related procedure) will be delivered per routine standard of care. |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2025-07-01
- Completion
- 2025-07-01
- First posted
- 2024-07-12
- Last updated
- 2026-01-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06497764. Inclusion in this directory is not an endorsement.