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
Overview
- Phase
- Not Applicable
- Intervention
- Vibrational Anesthesia (VA) Device
- Conditions
- Alopecia
- Sponsor
- NYU Langone Health
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure
- Status
- Withdrawn
- Last Updated
- 3 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have received at least one treatment of PRP to the scalp, which may include the PRP procedure performed day of.
- •Able to participate in study procedures.
- •Able to provide consent.
Exclusion Criteria
- •Patients missing the following data will be excluded from the final analysis: Patient age, gender, type of alopecia, PRP documentation.
- •Patients unable to consent.
Arms & Interventions
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.
Intervention: Vibrational Anesthesia (VA) Device
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.
Intervention: PRP Treatment
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.
Intervention: Vibrational Anesthesia (VA) Device
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.
Intervention: PRP Treatment
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure
Time Frame: End of procedure (About 10 minutes, Day 1)
At the end of the 10-minute PRP procedure, participants will rate their pain on: 1) The side of the scalp with no VA, and 2) the side of the scalp with VA. Participants will rate pain using a VAS, where pain is rated on a 0-10 scale; larger values indicate greater pain levels.
Secondary Outcomes
- Percentage of Participants who Opt to use VA among Participants in the "Control, then Intervention" Arm(Day 1)