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

Last updated: September 22, 2025
Sponsor: East Coast Institute for Research
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

DigiVibe Vibration Anesthesia

Clinical Study ID

NCT06987201
UACR-DIGI-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. BMI 18.5-29.9 kg/m2 (normal)

  3. Self-reported fear/dislike of needles

Exclusion

Exclusion Criteria:

  1. 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 usedwithin 3 days of study screening and enrollment
  1. 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 usedwithin 3 days of study screening and enrollment
  1. Any condition in the opinion of the study investigator that would potentiallyconfound the results of this study

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: DigiVibe Vibration Anesthesia
Phase:
Study Start date:
August 04, 2025
Estimated Completion Date:
August 15, 2025

Study Description

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.

Connect with a study center

  • Universal Axon Clinical Research, LLC

    Doral, Florida 33166
    United States

    Site Not Available

  • Universal Axon Clinical Research, LLC

    Doral 4153471, Florida 4155751 33166
    United States

    Site Not Available

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