E-MOHS Trial of TENS and Vibration During Local Anesthesia

Part of paid clinical trials in Maple Grove, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07852455
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Local Anesthesia
  • Mohs Surgery
  • Pain
  • Procedural Pain
  • Skin Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active Vibration:TENS — DEVICE
    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 — DEVICE
    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 Details

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.

Key Dates

First listed
Oct 1, 2026
Start date
Jan 1, 2027
Status verified
Oct 2026
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Active Vibration:TENS
    Participants will receive adjunctive high-frequency transcutaneous electrical nerve stimulation with vibratory distraction during local anesthetic infiltration for Mohs micrographic surgery or dermatologic excision.
  • Sham Comparator: Sham TENS
    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.

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
M Health Fairview ClinicMaple GroveMinnesota55369
M Health Fairview Clinic - OxboroMinneapolisMinnesota55420-
M Health Fairview Clinic - WyomingWyomingMinnesota55092
Andrew Fay
[email protected]
612-625-8625
Ian Maher, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Maple Grove, MN

Nationwide
Skin cancer trialsOncology trialsSkin cancer trialsDermatology trials
By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
M Health Fairview Clinic· Maple Grove, MNM Health Fairview Clinic - Oxboro· Minneapolis, MNM Health Fairview Clinic - Wyoming· Wyoming, MN

Related Studies