Status:
COMPLETED
Effects of DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks
Lead Sponsor:
East Coast Institute for Research
Collaborating Sponsors:
Universal Axon Clinical Research, LLC
Suthe Dermal
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
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/d...
Detailed 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 DigiV...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- BMI 18.5-29.9 kg/m2 (normal)
- Self-reported fear/dislike of needles
Exclusion
- 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
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06987201
Start Date
August 4 2025
End Date
August 15 2025
Last Update
September 25 2025
Active Locations (1)
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1
Universal Axon Clinical Research, LLC
Doral, Florida, United States, 33166