PainE-MOHSNCT07852455
E-MOHS Trial of TENS and Vibration During Local Anesthesia
A study testing Active Vibration:TENS in people with Pain and Procedural Pain, run by University of Minnesota at 3 sites in United States.
Trial summary
The E-MOHS Trial is a randomized controlled trial evaluating whether active vibration plus transcutaneous electrical nerve stimulation reduces pain during local anesthetic infiltration in adults undergoing Mohs micrographic surgery or dermatologic excision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Procedural Pain, Local Anesthesia
- What is being tested?
- Active Vibration:TENS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2027to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older scheduled for Mohs micrographic surgery under local anesthesia at a University of Minnesota or M Health Fairview dermatologic surgery clinic, or scheduled for dermatologic excision under local anesthesia as a pre-specified secondary population
- Able to understand and rate pain on the 11-point Numeric Rating Scale and 100 mm Visual Analog Scale
- Naive to transcutaneous electrical nerve stimulation, defined as no prior TENS exposure
- English-speaking and able to provide informed consent in English
Who cannot join
- Implanted cardiac pacemaker, implantable cardioverter-defibrillator, or other active implanted electronic device
- Surgical site requiring electrode placement over the anterior neck or carotid sinus region
- Pregnancy
- Epilepsy or other seizure disorder
- Metal implant at the intended electrode site
- Broken, infected, eczematous, or sensory-impaired skin at the intended electrode site
Show all 18Show fewer
- Inability to perceive or report the stimulus, including cognitive impairment, sedation, or local neuropathy
- Known lidocaine allergy
- Children
- Fetuses
- Neonates
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Non-English speakers
- Individuals unable to read
- Employees of the researcher
- Students of the researcher
- Individuals approached in emergency or acutely stressful settings
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
M Health Fairview Clinic
Maple Grove, Minnesota, 55369
Andrew Fay, afay@umn.edu
M Health Fairview Clinic - Oxboro
Minneapolis, Minnesota, 55420
M Health Fairview Clinic - Wyoming
Wyoming, Minnesota, 55092
Andrew Fay, 612-625-8625, afay@umn.edu
Ian Maher, MD
About this study
Official title: Electrostimulation and Vibration as a Non-Pharmacological Adjunct to Local Anesthesia in Mohs Micrographic and Dermatologic Surgery
The E-MOHS Trial is a randomized controlled trial evaluating whether active vibration plus transcutaneous electrical nerve stimulation reduces pain during local anesthetic infiltration in adults undergoing Mohs micrographic surgery or dermatologic excision.
Participants will be randomized to active vibration:TENS or sham TENS during the first local anesthetic administration. The primary outcome is patient-reported infiltration pain during active local anesthetic infiltration, measured using the 11-point Numeric Rating Scale.
Secondary outcomes include infiltration pain measured using a Visual Analog Scale, perioperative anxiety, participant satisfaction, willingness to reuse the device, operator-rated ease of use and sterile-field compatibility, blinding integrity, and adverse events.
Read the detailed description
Local anesthetic injection is a common source of pain and anxiety during Mohs micrographic surgery and dermatologic surgery. Physical counter-stimulation methods such as vibration and transcutaneous electrical nerve stimulation may reduce procedural pain through gate-control pain modulation.
The E-MOHS Trial is a parallel-group, two-arm, participant- and assessor-blinded randomized controlled trial. Adults undergoing Mohs micrographic surgery under local anesthesia, or dermatologic excision under local anesthesia in a pre-specified secondary population, will be enrolled on the day of surgery before the first local anesthetic administration.
Participants will be randomized 1:1 to active vibration:TENS or sham TENS. In the active arm, adhesive electrodes will be placed outside the sterile field and high-frequency transcutaneous electrical nerve stimulation will be applied during local anesthetic infiltration. A handheld vibration device will also be applied to intact skin adjacent to the injection site. In the sham arm, a fade-to-zero transient sham TENS device will be used to support blinding.
The primary endpoint is patient-reported pain of local anesthetic infiltration measured using the 11-point Numeric Rating Scale during active infiltration at the first anesthetic administration. Secondary outcomes include pain measured using a 100 mm Visual Analog Scale, perioperative anxiety, participant satisfaction, willingness to reuse the device, operator-rated ease of use and sterile-field compatibility, blinding integrity, and adverse events.
All research procedures occur during the scheduled surgical visit. No research-only follow-up visits are required. Adverse events will be monitored through the standard post-operative period as part of routine clinical care.
- Conditions
- Pain, Procedural Pain, Local Anesthesia, Mohs Surgery, Skin Cancer
- Being tested
- Active Vibration:TENS, Sham TENS
- Keywords
- E-MOHS, Local anesthesia, Local anesthetic infiltration, Procedural pain, Dermatologic surgery
- Medical subject headings
- Pain, Pain, Procedural, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Vibration:TENSDevice
Also called Transcutaneous Electrical Nerve Stimulation With Vibratory Distraction
Active high-frequency transcutaneous electrical nerve stimulation will be applied with adhesive electrodes placed outside the sterile field during local anesthetic infiltration. Stimulation will be titrated to a strong but comfortable, non-painful paresthesia and used with vibratory distraction adjacent to the injection site.
Sham TENSDevice
Also called Fade-to-Zero Sham Transcutaneous Electrical Nerve Stimulation
Sham transcutaneous electrical nerve stimulation will use a transient fade-to-zero current so that device titration appears similar to active treatment while preserving participant blinding.
| Study group | Role | What they receive |
|---|---|---|
| Active Vibration:TENS | Experimental | Participants will receive adjunctive high-frequency transcutaneous electrical nerve stimulation with vibratory distraction during local anesthetic infiltration for Mohs micrographic surgery or dermatologic excision. Receives: Device: Active Vibration:TENS |
| Sham TENS | Sham comparator | Participants will receive sham transcutaneous electrical nerve stimulation during local anesthetic infiltration. The sham device will deliver a fade-to-zero transient current to preserve blinding. Receives: Device: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During Local Anesthetic Infiltration Measured by Numeric Rating Scale
Patient-reported pain during local anesthetic infiltration will be measured using the 11-point Numeric Rating Scale, ranging from 0 to 10, during active infiltration at the first anesthetic administration.
Measured: During active local anesthetic infiltration at the first anesthetic administration
Secondary outcomes (7)
Pain During Local Anesthetic Infiltration Measured by Visual Analog Scale
Patient-reported pain during local anesthetic infiltration will be measured using the 100 mm Visual Analog Scale.
Measured: During active local anesthetic infiltration at the first anesthetic administration
Perioperative Anxiety Measured by Visual Analog Scale
Perioperative anxiety will be assessed using a 100 mm Visual Analog Scale. Participants will mark their anxiety level on a scale from 0 mm to 100 mm, with higher scores indicating greater anxiety.
Measured: Before local anesthetic administration on the day of surgery
Participant Satisfaction With the Infiltration Experience
Participant satisfaction with the local anesthetic infiltration experience will be assessed after the procedure using study-specific participant-reported measures.
Measured: Before local anesthetic administration on the day of surgery
Willingness to Reuse the Device
Participant willingness to use the device again in a future procedure will be assessed after the procedure.
Measured: After the procedure on the day of surgery
Operator-Rated Ease of Use and Sterile-Field Compatibility
The operator will rate device ease of use and compatibility with the sterile field after the procedure.
Measured: After the procedure on the day of surgery
Integrity of Participant Blinding
Blinding integrity will be assessed by asking participants to guess their assigned arm and rate their confidence. A blinding index will be derived.
Measured: After the procedure on the day of surgery
Adverse Events
Adverse events, including device-related events such as transient discomfort, skin irritation, or adhesive reaction, will be recorded during the procedure and through the standard post-operative period.
Measured: During the procedure and through 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants undergoing Mohs micrographic surgery, or dermatologic excision in a pre-specified secondary population, will be randomized 1:1 to active vibration plus transcutaneous electrical nerve stimulation or sham transcutaneous electrical nerve stimulation during local anesthetic infiltration. Randomization will be stratified by anatomic site and operator. Participants and the outcome assessor will be blinded to treatment assignment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Maher, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852455
- Sponsor's protocol ID
- DERM-2026-35224
- Acronym
- E-MOHS
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrostimulation and Vibration as a Non-Pharmacological Adjunct to Local Anesthesia in Mohs Micrographic and Dermatologic Surgery
- ClinicalTrials.gov ID
- NCT07852455
- Acronym / sponsor ID
- E-MOHS / DERM-2026-35224
- Conditions
- Pain, Procedural Pain, Local Anesthesia, Mohs Surgery, Skin Cancer
- Keywords
- E-MOHS, Local anesthesia, Local anesthetic infiltration, Procedural pain, Dermatologic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The E-MOHS Trial is a randomized controlled trial evaluating whether active vibration plus transcutaneous electrical nerve stimulation reduces pain during local anesthetic infiltration in adults undergoing Mohs micrographic surgery or dermatologic excision.
Participants will be randomized to active vibration:TENS or sham TENS during the first local anesthetic administration. The primary outcome is patient-reported infiltration pain during active local anesthetic infiltration, measured using the 11-point Numeric Rating Scale.
Secondary outcomes include infiltration pain measured using a Visual Analog Scale, perioperative anxiety, participant satisfaction, willingness to reuse the device, operator-rated ease of use and sterile-field compatibility, blinding integrity, and adverse events.
Detailed description
Local anesthetic injection is a common source of pain and anxiety during Mohs micrographic surgery and dermatologic surgery. Physical counter-stimulation methods such as vibration and transcutaneous electrical nerve stimulation may reduce procedural pain through gate-control pain modulation.
The E-MOHS Trial is a parallel-group, two-arm, participant- and assessor-blinded randomized controlled trial. Adults undergoing Mohs micrographic surgery under local anesthesia, or dermatologic excision under local anesthesia in a pre-specified secondary population, will be enrolled on the day of surgery before the first local anesthetic administration.
Participants will be randomized 1:1 to active vibration:TENS or sham TENS. In the active arm, adhesive electrodes will be placed outside the sterile field and high-frequency transcutaneous electrical nerve stimulation will be applied during local anesthetic infiltration. A handheld vibration device will also be applied to intact skin adjacent to the injection site. In the sham arm, a fade-to-zero transient sham TENS device will be used to support blinding.
The primary endpoint is patient-reported pain of local anesthetic infiltration measured using the 11-point Numeric Rating Scale during active infiltration at the first anesthetic administration. Secondary outcomes include pain measured using a 100 mm Visual Analog Scale, perioperative anxiety, participant satisfaction, willingness to reuse the device, operator-rated ease of use and sterile-field compatibility, blinding integrity, and adverse events.
All research procedures occur during the scheduled surgical visit. No research-only follow-up visits are required. Adverse events will be monitored through the standard post-operative period as part of routine clinical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants undergoing Mohs micrographic surgery, or dermatologic excision in a pre-specified secondary population, will be randomized 1:1 to active vibration plus transcutaneous electrical nerve stimulation or sham transcutaneous electrical nerve stimulation during local anesthetic infiltration. Randomization will be stratified by anatomic site and operator. Participants and the outcome assessor will be blinded to treatment assignment.
| Arm | Type | Receives |
|---|---|---|
| Active Vibration:TENS | Experimental | Device: Active Vibration:TENSParticipants will receive adjunctive high-frequency transcutaneous electrical nerve stimulation with vibratory distraction during local anesthetic infiltration for Mohs micrographic surgery or dermatologic excision. |
| Sham TENS | Sham comparator | Device: Sham TENSParticipants will receive sham transcutaneous electrical nerve stimulation during local anesthetic infiltration. The sham device will deliver a fade-to-zero transient current to preserve blinding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18 years of age or older scheduled for Mohs micrographic surgery under local anesthesia at a University of Minnesota or M Health Fairview dermatologic surgery clinic, or scheduled for dermatologic excision under local anesthesia as a pre-specified secondary population
- Able to understand and rate pain on the 11-point Numeric Rating Scale and 100 mm Visual Analog Scale
- Naive to transcutaneous electrical nerve stimulation, defined as no prior TENS exposure
- English-speaking and able to provide informed consent in English
Key exclusion criteria (18 listed)
- Implanted cardiac pacemaker, implantable cardioverter-defibrillator, or other active implanted electronic device
- Surgical site requiring electrode placement over the anterior neck or carotid sinus region
- Pregnancy
- Epilepsy or other seizure disorder
- Metal implant at the intended electrode site
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 |
|---|---|---|
| Active Vibration:TENSAlso: Transcutaneous Electrical Nerve Stimulation With Vibratory DistractionActive high-frequency transcutaneous electrical nerve stimulation will be applied with adhesive electrodes placed outside the sterile field during local anesthetic infiltration. Stimulation will be titrated to a strong but comfortable, non-painful paresthesia and used with vibratory distraction adjacent to the injection site. | Device | Active Vibration:TENS |
| Sham TENSAlso: Fade-to-Zero Sham Transcutaneous Electrical Nerve StimulationSham transcutaneous electrical nerve stimulation will use a transient fade-to-zero current so that device titration appears similar to active treatment while preserving participant blinding. | Device | Sham TENS |
Primary outcome
Pain During Local Anesthetic Infiltration Measured by Numeric Rating Scale
Time frame: During active local anesthetic infiltration at the first anesthetic administration
Patient-reported pain during local anesthetic infiltration will be measured using the 11-point Numeric Rating Scale, ranging from 0 to 10, during active infiltration at the first anesthetic administration.
7 secondary outcomes
Pain During Local Anesthetic Infiltration Measured by Visual Analog Scale
Time frame: During active local anesthetic infiltration at the first anesthetic administration
Perioperative Anxiety Measured by Visual Analog Scale
Time frame: Before local anesthetic administration on the day of surgery
Participant Satisfaction With the Infiltration Experience
Time frame: Before local anesthetic administration on the day of surgery
Willingness to Reuse the Device
Time frame: After the procedure on the day of surgery
Operator-Rated Ease of Use and Sterile-Field Compatibility
Time frame: After the procedure on the day of surgery
Integrity of Participant Blinding
Time frame: After the procedure on the day of surgery
Adverse Events
Time frame: During the procedure and through 3 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Ian Maher, MD principal investigator
University of Minnesota
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Vibration:TENS in people with Pain and Procedural Pain, run by University of Minnesota at 3 sites 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 4 inclusion and 18 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Fay (612-625-8625, afay@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain During Local Anesthetic Infiltration Measured by Numeric Rating Scale (time frame: During active local anesthetic infiltration at the first anesthetic administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.