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

NCT06265636 | Recruiting

• 1 other identifier: 2006202325523
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (2)

• Self-reported quality of life (SF-12)

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

• Electromyographic activation rate of the masseter muscle.

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Manual Therapy, exercise and percutaneous electrical nerve stimulation.

Procedure: Percutaneous nerve stimulation; Other: Manual therapy; Other: exercise

Control Group

ACTIVE COMPARATOR

Manual Therapy, exercise.

Other: Manual therapy; Other: exercise

Interventions

Percutaneous nerve stimulation PROCEDURE

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.

Also known as: PENS

Experimental Group

Manual therapy OTHER

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

Control Group; Experimental Group

exercise OTHER

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

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OrigenKinesis fisioterapia: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Origenkinesis Fisioterapia

Alcorcón, Madrid, 28925, Spain

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Transcutaneous Electric Nerve Stimulation; Musculoskeletal Manipulations; Exercise

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Complementary Therapies; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Hector Mardomingo Medialdea, Phd

CONTACT

+34 691683185; hectormardomingo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 20, 2024
• Study Start: February 17, 2024
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

ES (1)