HealthyVIB-DIGINCT06987201

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

A study testing DigiVibe Vibration Anesthesia in people with Healthy, run by East Coast Institute for Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: DigiVibe Vibration Anesthesia
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2025to 15 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥ 18 years
BMI 18.5-29.9 kg/m2 (normal)
Self-reported fear/dislike of needles

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Universal Axon Clinical Research, LLC
Doral, Florida, 33166

Other trials in United States

About this study

Official title: Prospective, Crossover, Open Label Study to Evaluate the Effects of Vibration Anesthesia With DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks (VIB-DIGI)

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.

Read the 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.

Conditions: Healthy
Being tested: DigiVibe Vibration Anesthesia
Keywords: DigiVibe, Vibration Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DigiVibe Vibration AnesthesiaDevice
DigiVibe Vibration Anesthesia

Study groups in NCT06987201
Study group	Role	What they receive
No DigiVibe	No intervention	Standard of Care
DigiVibe	Experimental	DigiVibe Vibration Anesthesia Receives: Device: DigiVibe Vibration Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202515 Aug 2025

First posted23 May 2025
Study start4 Aug 2025
Primary completion15 Aug 2025
Study completion15 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06987201
Sponsor's protocol ID: UACR-DIGI-01
Acronym: VIB-DIGI
Status last verified: Dec 2025
First submitted: 9 May 2025
Last updated: 14 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Only IPD used in the results publication

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Crossover, Open Label Study to Evaluate the Effects of Vibration Anesthesia With DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks (VIB-DIGI)
ClinicalTrials.gov ID: NCT06987201
Acronym / sponsor ID: VIB-DIGI / UACR-DIGI-01
Conditions: Healthy
Keywords: DigiVibe, Vibration Anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: East Coast Institute for ResearchResearch network
Collaborators: Universal Axon Clinical Research, LLC, Suthe Dermal
Study start: 4 Aug 2025 (actual)
Primary completion: 15 Aug 2025 (actual)
Study completion: 15 Aug 2025 (actual)
First posted: 23 May 2025 (actual)
Results: Posted 14 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
No DigiVibe	No intervention	–Standard of Care
DigiVibe	Experimental	Device: DigiVibe Vibration AnesthesiaDigiVibe Vibration Anesthesia

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥ 18 years
BMI 18.5-29.9 kg/m2 (normal)
Self-reported fear/dislike of needles

Key exclusion criteria (5 listed)

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.)
Chronic (daily) use of analgesics (i.e. acetaminophen, NSAIDs [ie. ibuprofen, naproxen], opioids [ie. morphine, oxycodone, fentanyl], lidocaine, cannabinoids [ie. CBD, THC],)
Any condition in the opinion of the study investigator that would potentially confound the results of this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DigiVibe Vibration AnesthesiaDigiVibe Vibration Anesthesia	Device	DigiVibe

Primary outcome

Mean Visual Analogue Scale (VAS) Pain Scale
Time frame: 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.

Results and safety

Results posted to the registry on 14 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No DigiVibe (SOC), Then Digivibe	20	20

Primary outcome: Mean Visual Analogue Scale (VAS) Pain Scale

Time frame: 1 day. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	No DigiVibe First (SOC), Then DigiVibe n = 20
Mean VAS for Abdomen SC (30G, 4mm needle) - SOC	3.75 (3.01 to 4.49)
Mean VAS for Abdomen SC (30G, 4mm needle) - With DigiVibe	1.10 (0.60 to 1.60)
Mean VAS for total Deltoid (25G and 30G, 1 inch needle) - SOC	3.85 (3.07 to 4.63)
Mean VAS for total Deltoid (25G and 30G, 1 inch needle) - With DiVibe	1.85 (1.24 to 2.46)
Mean VAS for Deltoid (25G only, 1 inch needle) - SOC	4.40 (3.22 to 5.58)
Mean VAS for Deltoid (25G only, 1 inch needle) - With DigiVibe	1.90 (0.76 to 3.04)
Mean VAS for Deltoid (30G only, 1 inch needle) - SOC	3.30 (2.18 to 4.42)
Mean VAS for Deltoid (30G only, 1 inch needle) - With DigiVibe	1.80 (1.06 to 2.54)

No DigiVibe First (SOC), Then DigiVibe: Mean Difference (Final Values): -2.650 (95% CI -3.398 to -1.902), p <0.001, t-test, 2 sided

Population analysed: 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).

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No DigiVibe (SOC), Then Digivibe	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): Lack of sham control and blinding.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Only IPD used in the results publication

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DigiVibe Vibration Anesthesia in people with Healthy, run by East Coast Institute for Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Visual Analogue Scale (VAS) Pain Scale (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06987201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.