N/A
N=20
Effects of DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT06987201 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Mean Visual Analogue Scale (VAS) Pain Scale — 3.75; 1.10; 3.85; 1.85 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DigiVibe Vibration Anesthesia (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- East Coast Institute for Research
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Visual Analogue Scale (VAS) Pain Scale |
3.75; 1.10; 3.85; 1.85; 4.40; 1.90 | <0.001 sig |
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 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
Data sourced from ClinicalTrials.gov (NCT06987201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.