University of Minnesota
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.
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…
Inclusion Criteria: * 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 Exclusion Criteria: * Implanted cardiac…
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 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.