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Completed

NCT Number: NCT06987201

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universal Axon Clinical Research, LLC

Doral, Florida, 33166, United States

About this study

While the complete mechanisms of pain and pain diversion are not completely understood, DigiVibe locally targets the skin's pain receptors. Therefore, it is proposed that the vibrations from the DigiVibe device will counteract and/or lessen the pain around the injection site. This study will determine whether the use of DigiVibe during a procedure requiring injections provides greater reduction in pain than injections with no intervention (standard of care). This information will aid healthcare providers in selecting the best approach to management of pain in patients who must undergo injections that could cause pain and may benefit from additional pain reduction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

DigiVibe Vibration Anesthesia

Device

DigiVibe Vibration Anesthesia

Primary outcomes

  1. Mean Visual Analogue Scale (VAS) Pain Scale

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

East Coast Institute for Research

Network

Collaborators

  • Suthe Dermal
  • Universal Axon Clinical Research, LLC

Registry information

Official study title

Prospective, Crossover, Open Label Study to Evaluate the Effects of Vibration Anesthesia With DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks (VIB-DIGI)

Acronym: VIB-DIGI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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