protocolSection identificationModule nctId: NCT06265636, orgStudyIdInfo id: 2006202325523, briefTitle: Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders, acronym: Origenkine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-17, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2026-05-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: OrigenKinesis fisioterapia, class: OTHER, collaborators name: Universidad Rey Juan Carlos, descriptionModule briefSummary: Temporomandibular disorders (TMD) encompass dysfunction and pain of the masticatory muscles and temporomandibular joint (TMJ). Pain in the TMJ, restricted jaw movement, and joint sounds are common conditions in this disorder. This can impact patients' ability to perform daily activities such as eating, speaking, laughing, or yawning, significantly affecting their quality of life.The TMJ and masticatory muscles are innervated by the auriculotemporal branch and the mandibular nerve (V3), a branch of the trigeminal nerve. An estimated 60% to 70% of the population shows signs of TMD, of which up to 12% report intense symptoms requiring treatment.Percutaneous electrical nerve stimulation (PENS) could be a clinically relevant therapy in TMD patients applied through minimally invasive physiotherapy. To our knowledge, there are no trials evaluating the non-surgical clinical efficacy of PENS on the mandibular nerve.The project's objective is to assess the effectiveness of PENS on the mandibular nerve in this type of condition., conditionsModule conditions: Temporomandibular Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects who participate in the study will receive, in the case of the experimental group, 10 minutes of manual therapy and exercises and 10 minutes of percutaneous electrical nerve stimulation (PENS) guided by ultrasound. In the case of the control group, they will receive 20 minutes of manual therapy and exercises. The treatment will consist of one session per week for three weeks (a total of 3 sessions). Each session will last 30 minutes, of which 10 minutes will be used for the initial evaluation and 20 minutes for the assigned treatment. Two weeks after the last session, a final evaluation without treatment will be performed., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Percutaneous nerve stimulation, interventions name: Manual therapy, interventions name: exercise, outcomesModule primaryOutcomes measure: pain intensity, primaryOutcomes measure: Pressure pain thresholds (PPT), primaryOutcomes measure: Pain-free mandibular opening range of motion, secondaryOutcomes measure: Self-reported quality of life (SF-12), secondaryOutcomes measure: Electromyographic activation rate of the masseter muscle., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-25, uploadDate: 2024-02-10T07:04, filename: Prot_SAP_000.pdf, size: 142975, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-25, uploadDate: 2024-02-10T07:19, filename: ICF_001.pdf, size: 185452, hasResults: False