Effects of DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks

NCT06987201 | Completed Results

• 1 other identifier: UACR-DIGI-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, unblinded, prospective, cross-over study. The study population will include twenty (n=20) healthy subjects (10 men and 10 women) over the age of 18 with a self-reported fear/dislike of needles. Subjects who qualify for the study based on the study inclusion and exclusion criteria and who consent to participate in the study will undergo two (2) intramuscular (IM) injections in the deltoid muscle, two (2) subcutaneous (SC) injections in the abdomen, and two (2) fingersticks with a lancing device in the middle finger. One injection in each location will be performed using with no intervention (as per standard of care) and the other injection in each location will be performed using the DigiVibe device.

Conditions

Healthy

Keywords

DigiVibe; Vibration Anesthesia

Outcome Measures

Primary Outcomes (1)

• Mean Visual Analogue Scale (VAS) Pain Scale

  The original pain scores (Higher scores = worse pain) were represented by a grading scale of zero (0) to ten (10) on the VAS pain scale questionnaire. The mean in the values is represented by the mean of the original VAS scores without DigiVibe or with DigiVibe across all the participants and injection types.

  1 day

Study Arms (2)

No DigiVibe

NO INTERVENTION

Standard of Care

DigiVibe

EXPERIMENTAL

DigiVibe Vibration Anesthesia

Device: DigiVibe Vibration Anesthesia

Interventions

DigiVibe Vibration Anesthesia DEVICE

DigiVibe Vibration Anesthesia

DigiVibe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• BMI 18.5-29.9 kg/m2 (normal)
• Self-reported fear/dislike of needles

You may not qualify if:

• Chronic (daily) use of nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen, aspirin, naproxen, etc.), antiplatelet medications (i.e. clopidogrel, prasugrel, ticagrelor, cangrelor, cilostazol, etc), or anticoagulant medications (i.e. warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, heparin, enoxaparin, fondaparinux, etc.)
• Note: NSAIDs used as needed are not excluded as long as they are not used within 3 days of study screening and enrollment
• Chronic (daily) use of analgesics (i.e. acetaminophen, NSAIDs \[ie. ibuprofen, naproxen\], opioids \[ie. morphine, oxycodone, fentanyl\], lidocaine, cannabinoids \[ie. CBD, THC\],)
• Note: analgesics used as needed are not excluded as long as they are not used within 3 days of study screening and enrollment
• Any condition in the opinion of the study investigator that would potentially confound the results of this study

Sponsors & Collaborators

• East Coast Institute for Research: lead
• Universal Axon Clinical Research, LLC: collaborator
• Suthe Dermal: collaborator

Study Sites (1)

Universal Axon Clinical Research, LLC

Doral, Florida, 33166, United States

Location

Limitations and Caveats

Lack of sham control and blinding.

Results Point of Contact

• Title: Rebecca Goldfaden, PharmD, CCRP
• Organization: East Coast Institute for Research at Universal Axon Clinical Research

rg@roviaclinical.com

904-854-1354

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 23, 2025
• Study Start: August 4, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: May 15, 2025 through July 31, 2025

Locations

US (1)