NCT07852455

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
20mo left

Started Jan 2027

Typical duration for not_applicable pain

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 21, 2026

Last Update Submit

September 25, 2026

Conditions

PainProcedural PainLocal AnesthesiaMohs SurgerySkin Cancer

Keywords

E-MOHSLocal anesthesiaLocal anesthetic infiltrationProcedural painDermatologic surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    During active local anesthetic infiltration at the first anesthetic administration

Secondary Outcomes (7)

  • Pain During Local Anesthetic Infiltration Measured by Visual Analog Scale

    During active local anesthetic infiltration at the first anesthetic administration

  • Perioperative Anxiety Measured by Visual Analog Scale

    Before local anesthetic administration on the day of surgery

  • Participant Satisfaction With the Infiltration Experience

    Before local anesthetic administration on the day of surgery

  • Willingness to Reuse the Device

    After the procedure on the day of surgery

  • Operator-Rated Ease of Use and Sterile-Field Compatibility

    After the procedure on the day of surgery

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Device: Sham TENS

Interventions

Active Vibration:TENSDEVICE

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.

Also known as: Transcutaneous Electrical Nerve Stimulation With Vibratory Distraction
Active Vibration:TENS
Sham TENSDEVICE

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.

Also known as: Fade-to-Zero Sham Transcutaneous Electrical Nerve Stimulation
Sham TENS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

M Health Fairview Clinic - Oxboro

Minneapolis, Minnesota, 55420, United States

Location

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, 55455, United States

Location

M Health Fairview Clinic - Wyoming

Wyoming, Minnesota, 55092, United States

Location

MeSH Terms

Conditions

PainPain, ProceduralSkin Neoplasms

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Ian Maher, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Fay

CONTACT

612-625-8625afay@umn.edu

Ian Maher, MD

CONTACT

612-625-8625imaher@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2026

First Posted

October 1, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations

US(3)