[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658497":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":50,"studyPopulation":38,"armGroups":51,"interventions":64,"overallOfficials":76,"centralContacts":80,"locations":88,"responsibleParty":125,"collaborators":38,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":129,"sex":135,"minAge":136,"maxAge":38,"enrollmentInfo":137,"targetDuration":38,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":150,"overallStatus":155,"whyStopped":38,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"University of Minnesota","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,21,24,28,31,34],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":20},"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.","Before local anesthetic administration on the day of surgery",{"measure":22,"description":23,"timeFrame":20},"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.",{"measure":25,"description":26,"timeFrame":27},"Willingness to Reuse the Device","Participant willingness to use the device again in a future procedure will be assessed after the procedure.","After the procedure on the day of surgery",{"measure":29,"description":30,"timeFrame":27},"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.",{"measure":32,"description":33,"timeFrame":27},"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.",{"measure":35,"description":36,"timeFrame":37},"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.","During the procedure and through 3 months after surgery.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","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.","SUPPORTIVE_CARE",{"masking":45,"maskingDescription":38,"whoMasked":46},"TRIPLE",[47,48,49],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nThe 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.\n\nParticipants 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.\n\nThe 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.\n\nAll 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.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"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.",[57],"Device: Active Vibration:TENS",{"label":59,"type":60,"description":61,"interventionNames":62},"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.",[63],"Device: Sham TENS",[65,71],{"type":66,"name":53,"description":67,"armGroupLabels":68,"otherNames":69},"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.",[53],[70],"Transcutaneous Electrical Nerve Stimulation With Vibratory Distraction",{"type":66,"name":59,"description":72,"armGroupLabels":73,"otherNames":74},"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.",[59],[75],"Fade-to-Zero Sham Transcutaneous Electrical Nerve Stimulation",[77],{"name":78,"affiliation":5,"role":79},"Ian Maher, MD","PRINCIPAL_INVESTIGATOR",[81,86],{"name":82,"role":83,"phone":84,"phoneExt":38,"email":85},"Andrew Fay","CONTACT","612-625-8625","afay@umn.edu",{"name":78,"role":83,"phone":84,"phoneExt":38,"email":87},"imaher@umn.edu",[89,104,113],{"facility":90,"status":38,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"M Health Fairview Clinic","Maple Grove","Minnesota","55369","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-93.45579,45.07246,{"lat":100,"lon":99},[103],{"name":82,"role":83,"phone":38,"phoneExt":38,"email":85},{"facility":105,"status":38,"city":106,"state":92,"zip":107,"country":94,"countryCode":95,"cosmosGeoPoint":108,"geoPoint":112,"contacts":38},"M Health Fairview Clinic - Oxboro","Minneapolis","55420",{"type":97,"coordinates":109},[110,111],-93.26384,44.97997,{"lat":111,"lon":110},{"facility":114,"status":38,"city":115,"state":92,"zip":116,"country":94,"countryCode":95,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"M Health Fairview Clinic - Wyoming","Wyoming","55092",{"type":97,"coordinates":118},[119,120],-92.99716,45.33636,{"lat":120,"lon":119},[123,124],{"name":82,"role":83,"phone":84,"phoneExt":38,"email":85},{"name":78,"role":79,"phone":38,"phoneExt":38,"email":38},{"type":126,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100658497","e-mohs-trial-of-tens-and-vibration-during-local-anesthesia-100658497",false,"NCT07852455","E-MOHS Trial of TENS and Vibration During Local Anesthesia","Electrostimulation and Vibration as a Non-Pharmacological Adjunct to Local Anesthesia in Mohs Micrographic and Dermatologic Surgery","E-MOHS","Inclusion Criteria:\n\n* 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\n* Able to understand and rate pain on the 11-point Numeric Rating Scale and 100 mm Visual Analog Scale\n* Naive to transcutaneous electrical nerve stimulation, defined as no prior TENS exposure\n* English-speaking and able to provide informed consent in English\n\nExclusion Criteria:\n\n* Implanted cardiac pacemaker, implantable cardioverter-defibrillator, or other active implanted electronic device\n* Surgical site requiring electrode placement over the anterior neck or carotid sinus region\n* Pregnancy\n* Epilepsy or other seizure disorder\n* Metal implant at the intended electrode site\n* Broken, infected, eczematous, or sensory-impaired skin at the intended electrode site\n* Inability to perceive or report the stimulus, including cognitive impairment, sedation, or local neuropathy\n* Known lidocaine allergy\n* Children\n* Fetuses\n* Neonates\n* Prisoners\n* Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent\n* Non-English speakers\n* Individuals unable to read\n* Employees of the researcher\n* Students of the researcher\n* Individuals approached in emergency or acutely stressful settings","ALL","18 Years",{"count":138,"type":139},90,"ESTIMATED","INTERVENTIONAL",[142],"NA","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.\n\nParticipants 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.\n\nSecondary 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.",[145,146,147,148,149],"Pain","Procedural Pain","Local Anesthesia","Mohs Surgery","Skin Cancer",[133,151,152,153,154],"Local anesthesia","Local anesthetic infiltration","Procedural pain","Dermatologic surgery","NOT_YET_RECRUITING","2026-10-01",{"date":158,"type":159},"2026-10-06","ACTUAL",{"date":161,"type":139},"2027-01-01",{"date":163,"type":139},"2028-08-31",{"name":5,"class":6},3]