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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOrigenKinesis fisioterapia

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Percutaneous nerve stimulation

    Procedure/Surgery

    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

    Other intervention

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

  • exercise

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 3 interventions
Group B: Control GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

pain intensity

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.

Time frame
At the beginning of each intervention session and one month after the end of the last intervention.
2

Pressure pain thresholds (PPT)

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.

Time frame
At the beginning of each intervention session and one month after the end of the last intervention.
3

Pain-free mandibular opening range of motion

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.

Time frame
At the beginning of each intervention session and one month after the end of the last intervention.

Secondary outcomes

1

Self-reported quality of life (SF-12)

The SF-12 Life Satisfaction Scale measures health-related quality of life. While not directly scoring life satisfaction, it assesses physical and mental health perceptions. Scores for each dimension provide insights into overall life satisfaction. The SF-12 comprises 12 questions across 8 dimensions, such as physical limitations, social roles, pain, and mental health. These yield two summary components: Physical Component Summary (PCS) and Mental Component Summary (MCS). Scores, standardized with a mean of 50 and a standard deviation of 10 in the general population, indicate better health-related quality of life with higher scores.

Time frame
At the beginning of the first intervention and one month after the last intervention.
2

Electromyographic activation rate of the masseter muscle.

The surface EMG recording will be obtained using an 11 mDurance® four-channel surface electromyograph. The unit of measurement will be in picovolts. Higher picovolt detection indicates greater muscle excitability. Visual graphs will be used to represent the amount of activation of the masseter muscle. The EMG signal was captured in two tasks: during resting mandibular position (MR) and during a 5-second sustained maximum occlusion contraction (MVC).

Time frame
At the beginning of the first intervention and one month after the last intervention.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OrigenKinesis fisioterapia

Lead sponsor

Universidad Rey Juan Carlos

Collaborator