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Recruiting Not applicable

Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders

NCT06265636 · tracked via the Priya Life Science Spain tracker
Sponsor
OrigenKinesis fisioterapia
Phase
Not applicable
Started
2024-02-17
Last updated
2025-08-05

Condition(s) studied

Temporomandibular Disorder

Investigational drug(s) / intervention(s)

Percutaneous nerve stimulationManual therapyexercise

Percutaneous nerve stimulation: Percutaneous nerve stimulation (PENS) involves inserting a dry needling needle through muscle tissue until it reaches a nerve branch. At this point, a bipolar TENS current with different parameters is applied to the needle with the goal of improving the patient's pain perception.

Manual therapy: Digital pressure techniques in muscle areas with the aim of reducing the perception of stiffness and pain

exercise: Exercises for improving mandibular mobility, occlusion coordination and regulation of temporomandibular muscle tone

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • pain intensity — At the beginning of each intervention session and one month after the end of the last intervention.
    Numerical Pain Rating Scale (NPRS) (Appendix 2). Pain at rest and with chewing on a visual analogue scale. The minimum value is 0, and the maximum is 10. Higher values indicate more pain.
  • Pressure pain thresholds (PPT) — At the beginning of each intervention session and one month after the end of the last intervention.
    A pressure algometer (kg/cm2) will be used. The measurement will be taken with which the minimum amount of pressure applied to the masseter muscle produces pain.
  • Pain-free mandibular opening range of motion — At the beginning of each intervention session and one month after the end of the last intervention.
    herabite® System ruler (Appendix 3). 6 mm has been determined as the minimum detectable change in maximum mouth opening \[56\]. Mandibular range of motion (maximum mouth opening) will be measured with a device that allows the evaluation of mouth movements in millimeters.

Trial sites (1)

FacilityCityRegionStatus
Origenkinesis Fisioterapia Alcorcón Madrid Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06265636 on ClinicalTrials.gov ↗ ← All trials in Spain