Healthy
Conditions
Keywords
DigiVibe, Vibration Anesthesia
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/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.
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 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.
Interventions
DEVICEDigiVibe Vibration Anesthesia
DigiVibe Vibration Anesthesia
Sponsors
Universal Axon Clinical Research, LLC
Suthe Dermal
East Coast Institute for Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 18 years 2. BMI 18.5-29.9 kg/m2 (normal) 3. Self-reported fear/dislike of needles
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 used within 3 days of study screening and enrollment 2. 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 3. Any condition in the opinion of the study investigator that would potentially confound the results of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual Analogue Scale (VAS) Pain Scale | 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. |
Countries
United States
Participant flow
Recruitment details
1. Males and Females Age ≥ 18 years 2. BMI 18.5-29.9 kg/m2 (normal) 3. Self-reported fear/dislike of needles
Pre-assignment details
1. Males and Females Age ≥ 18 years 2. BMI 18.5-29.9 kg/m2 (normal) 3. Self-reported fear/dislike of needles
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | No DigiVibe (SOC), Then Digivibe |
|---|---|
| Age, Continuous | 37.5 Years STANDARD_DEVIATION 13.4 |
| Body Mass Index (BMI) | 26 kg/m2 STANDARD_DEVIATION 2.4 |
| Diastolic Blood Pressure (DBP) | 71.1 mmHg STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 308 Inches STANDARD_DEVIATION 18.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
| Systolic Blood Pressure (SBP) | 115.4 mmHg STANDARD_DEVIATION 8.3 |
| Weight | 157.5 Lbs STANDARD_DEVIATION 22.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Mean Visual Analogue Scale (VAS) Pain Scale
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.
Time frame: 1 day
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No DigiVibe First (SOC), Then DigiVibe | Mean Visual Analogue Scale (VAS) Pain Scale | Mean VAS for Abdomen SC (30G, 4mm needle) - SOC | 3.75 Units on a scale |
| No DigiVibe First (SOC), Then DigiVibe | Mean Visual Analogue Scale (VAS) Pain Scale | Mean VAS for Abdomen SC (30G, 4mm needle) - With DigiVibe | 1.10 Units on a scale |
| No DigiVibe First (SOC), Then DigiVibe | 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 |
| No DigiVibe First (SOC), Then DigiVibe | 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 |
| No DigiVibe First (SOC), Then DigiVibe | Mean Visual Analogue Scale (VAS) Pain Scale | Mean VAS for Deltoid (25G only, 1 inch needle) - SOC | 4.40 Units on a scale |
| No DigiVibe First (SOC), Then DigiVibe | Mean Visual Analogue Scale (VAS) Pain Scale | Mean VAS for Deltoid (25G only, 1 inch needle) - With DigiVibe | 1.90 Units on a scale |
| No DigiVibe First (SOC), Then DigiVibe | Mean Visual Analogue Scale (VAS) Pain Scale | Mean VAS for Deltoid (30G only, 1 inch needle) - SOC | 3.30 Units on a scale |
| No DigiVibe First (SOC), Then DigiVibe | Mean Visual Analogue Scale (VAS) Pain Scale | Mean VAS for Deltoid (30G only, 1 inch needle) - With DigiVibe | 1.80 Units on a scale |
| No DigiVibe First (SOC), Then DigiVibe | Mean Visual Analogue Scale (VAS) Pain Scale | Mean VAS for Fingerstick (30G, 1.5 mm needle) - SOC | 2.35 Units on a scale |
| No DigiVibe First (SOC), Then DigiVibe | Mean Visual Analogue Scale (VAS) Pain Scale | Mean VAS for Fingerstick (30G, 1.5 mm needle) - With DigiVibe | 0.60 Units on a scale |
p-value: <0.00195% CI: [-3.398, -1.902]t-test, 2 sided