NCT06265636 Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders
| NCT ID | NCT06265636 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OrigenKinesis fisioterapia |
| Condition | Temporomandibular Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-17 |
| Primary Completion | 2027-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-02-17 with a primary completion date of 2027-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients with local myofascial pain and/or increased tension in the masticatory muscles. * Patients with myofascial pain from temporomandibular disorder (TMD) at the time, diagnosed according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). * Absence of temporomandibular disc displacement with or without reduction. * Pain in the masticatory muscles associated with limited mouth opening (\<40mm). * Good general health (absence of chronic diseases that may affect the temporomandibular joint or masticatory muscles). * Written consent to participate in the study. Exclusion Criteria: * Injury to the face or head during the research participation. * Undergone surgical procedures performed in the craniocervical region and degenerative neurological diseases. * Sudden illness of the patient that prevented participation in the study. * Will to end participation in the study. * Less than 2 weeks of evolution. * Inability to understand instructions or sign the informed consent. * Minor patients. * Regular medication, such as muscle relaxants, anticonvulsants, antidepressants, or anxiolytics * Facial paralysis. * Presenting a disease or infectious/inflammatory process of dental origin.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06265636 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Temporomandibular Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06265636 currently recruiting?
Yes, NCT06265636 is actively recruiting participants. Contact the research team at hectormardomingo@hotmail.com for enrollment information.
Where is the NCT06265636 trial being conducted?
This trial is being conducted at Alcorcón, Spain.
Who is sponsoring the NCT06265636 clinical trial?
NCT06265636 is sponsored by OrigenKinesis fisioterapia. The trial plans to enroll 40 participants.