Trial Outcomes & Findings for Effects of DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks (NCT NCT06987201)
NCT ID: NCT06987201
Last Updated: 2026-01-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
1 day
Results posted on
2026-01-14
Participant Flow
1. Males and Females Age ≥ 18 years 2. BMI 18.5-29.9 kg/m2 (normal) 3. Self-reported fear/dislike of needles
1. Males and Females Age ≥ 18 years 2. BMI 18.5-29.9 kg/m2 (normal) 3. Self-reported fear/dislike of needles
Participant milestones
| Measure |
No DigiVibe (SOC), Then Digivibe
Participants received two rounds of injections with and without vibration anesthesia (DigiVibe) and completed Visual Analog Scale (VAS) pain scales immediately following the both rounds of injections. The first round of injections involved the Standard of Care (SOC) (injections without vibration anesthesia) with one subcutaneous abdomen (30G, 4mm needle with normal saline), one intramuscular deltoid (either 25G or 30G, 1 inch needles with normal saline), and one fingerstick (30G, 1.5 mm needle). After waiting 5 minutes, the DigVibe vibration anesthesia device was applied for 20 seconds (before and during lancing) and the second abdomen, deltoid, and fingerstick injections were administered.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
SOC: Abdomen SC (30G, 4mm needle)
|
20
|
|
Overall Study
DigiVibe: Abdomen SC (30G, 4mm needle)
|
20
|
|
Overall Study
SOC: Deltoid IM (25G only, 1 inch needle)
|
10
|
|
Overall Study
Digivibe: Deltoid IM (25G only, 1 inch needle)
|
10
|
|
Overall Study
SOC: Deltoid IM (30G only, 1 inch needle)
|
10
|
|
Overall Study
Digivibe: Deltoid IM (30G only, 1 inch needle)
|
10
|
|
Overall Study
SOC: Fingerstick (30G, 1.5 mm needle)
|
20
|
|
Overall Study
Digivibe: Fingerstick (30G, 1.5 mm needle)
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age of individuals who received injections without Digivibe and then with Digivibe
Baseline characteristics by cohort
| Measure |
No DigiVibe (SOC), Then Digivibe
n=20 Participants
Participants received two rounds of injections with and without vibration anesthesia (DigiVibe) and completed Visual Analog Scale (VAS) pain scales immediately following the both rounds of injections. The first round of injections involved the Standard of Care (SOC) (injections without vibration anesthesia) with one subcutaneous abdomen (30G, 4mm needle with normal saline), one intramuscular deltoid (either 25G or 30G, 1 inch needles with normal saline), and one fingerstick (30G, 1.5 mm needle). After waiting 5 minutes, the DigVibe vibration anesthesia device was applied for 20 seconds (before and during lancing) and the second abdomen, deltoid, and fingerstick injections were administered.
|
|---|---|
|
Age, Continuous
|
37.5 Years
STANDARD_DEVIATION 13.4 • n=14 Participants • Age of individuals who received injections without Digivibe and then with Digivibe
|
|
Sex: Female, Male
Female
|
10 Participants
n=14 Participants • Sex of individuals who received injections without Digivibe and then with Digivibe
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants • Sex of individuals who received injections without Digivibe and then with Digivibe
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants • Race of individuals who received injections without Digivibe and then with Digivibe
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants • Race of individuals who received injections without Digivibe and then with Digivibe
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants • Race of individuals who received injections without Digivibe and then with Digivibe
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants • Race of individuals who received injections without Digivibe and then with Digivibe
|
|
Race (NIH/OMB)
White
|
20 Participants
n=14 Participants • Race of individuals who received injections without Digivibe and then with Digivibe
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants • Race of individuals who received injections without Digivibe and then with Digivibe
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants • Race of individuals who received injections without Digivibe and then with Digivibe
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=14 Participants • Ethnicity of individuals who received injections without Digivibe and then with Digivibe
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=14 Participants • Ethnicity of individuals who received injections without Digivibe and then with Digivibe
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants • Ethnicity of individuals who received injections without Digivibe and then with Digivibe
|
|
Height
|
308 Inches
STANDARD_DEVIATION 18.9 • n=14 Participants • Height of individuals who received injections without Digivibe and then with Digivibe
|
|
Weight
|
157.5 Lbs
STANDARD_DEVIATION 22.9 • n=14 Participants
|
|
Body Mass Index (BMI)
|
26 kg/m2
STANDARD_DEVIATION 2.4 • n=14 Participants
|
|
Systolic Blood Pressure (SBP)
|
115.4 mmHg
STANDARD_DEVIATION 8.3 • n=14 Participants
|
|
Diastolic Blood Pressure (DBP)
|
71.1 mmHg
STANDARD_DEVIATION 7.6 • n=14 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Pain scores of individuals who acted as their own control after receiving 6 total injections and completed a Visual Analog Scale (VAS) pain scales immediately following the both rounds of injections (no DigiVibe compared to injections with DigiVibe).
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.
Outcome measures
| Measure |
No DigiVibe First (SOC), Then DigiVibe
n=20 Participants
Participants received two rounds of injections with and without vibration anesthesia (DigiVibe) and completed Visual Analog Scale (VAS) pain scales immediately following the both rounds of injections. The first round of injections involved the Standard of Care (SOC) (injections without vibration anesthesia) with one subcutaneous abdomen (30G, 4mm needle with normal saline), one intramuscular deltoid (either 25G or 30G, 1 inch needles with normal saline), and one fingerstick (30G, 1.5 mm needle). After waiting 5 minutes, the DigVibe vibration anesthesia device was applied for 20 seconds (before and during lancing) and the second abdomen, deltoid, and fingerstick injections were administered.
|
|---|---|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for Abdomen SC (30G, 4mm needle) - SOC
|
3.75 Units on a scale
Interval 3.01 to 4.49
|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for Abdomen SC (30G, 4mm needle) - With DigiVibe
|
1.10 Units on a scale
Interval 0.6 to 1.6
|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for total Deltoid (25G and 30G, 1 inch needle) - SOC
|
3.85 Units on a scale
Interval 3.07 to 4.63
|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for total Deltoid (25G and 30G, 1 inch needle) - With DiVibe
|
1.85 Units on a scale
Interval 1.24 to 2.46
|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for Deltoid (25G only, 1 inch needle) - SOC
|
4.40 Units on a scale
Interval 3.22 to 5.58
|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for Deltoid (25G only, 1 inch needle) - With DigiVibe
|
1.90 Units on a scale
Interval 0.76 to 3.04
|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for Deltoid (30G only, 1 inch needle) - SOC
|
3.30 Units on a scale
Interval 2.18 to 4.42
|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for Deltoid (30G only, 1 inch needle) - With DigiVibe
|
1.80 Units on a scale
Interval 1.06 to 2.54
|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for Fingerstick (30G, 1.5 mm needle) - SOC
|
2.35 Units on a scale
Interval 1.72 to 2.98
|
|
Mean Visual Analogue Scale (VAS) Pain Scale
Mean VAS for Fingerstick (30G, 1.5 mm needle) - With DigiVibe
|
0.60 Units on a scale
Interval 0.13 to 1.07
|
Adverse Events
No DigiVibe (SOC), Then Digivibe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rebecca Goldfaden, PharmD, CCRP
East Coast Institute for Research at Universal Axon Clinical Research
Phone: 904-854-1354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place