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E-MOHS Trial of TENS and Vibration During Local Anesthesia
Sponsor: University of Minnesota
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.
Official title: Electrostimulation and Vibration as a Non-Pharmacological Adjunct to Local Anesthesia in Mohs Micrographic and Dermatologic Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2027-01-01
Completion Date
2028-08-31
Last Updated
2026-10-06
Healthy Volunteers
No
Interventions
Active Vibration:TENS
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 TENS
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.
Locations (3)
M Health Fairview Clinic
Maple Grove, Minnesota, United States
M Health Fairview Clinic - Oxboro
Minneapolis, Minnesota, United States
M Health Fairview Clinic - Wyoming
Wyoming, Minnesota, United States