Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06265636

Transcutaneous Mandibular Nerve Electrical Stimulation for Pain and Function in Temporomandibular Disorder Patients

Led by OrigenKinesis fisioterapia · Updated on 2025-08-05

40

Participants Needed

1

Research Sites

14 weeks

Total Duration

On this page

Sponsors

O

OrigenKinesis fisioterapia

Lead Sponsor

U

Universidad Rey Juan Carlos

Collaborating Sponsor

AI-Summary

What this Trial Is About

Temporomandibular disorders (TMD) cause pain and dysfunction in the jaw muscles and joint, affecting daily activities like eating, speaking, and yawning. These disorders are common, impacting 60% to 70% of people, with up to 12% experiencing severe symptoms needing treatment. This research evaluates the use of percutaneous electrical nerve stimulation (PENS), a minimally invasive therapy, targeting the mandibular nerve to manage pain and improve function in TMD patients. Participants will be randomly assigned to one of two groups: one receiving manual therapy, exercise, and PENS, and the other receiving manual therapy and exercise only. PENS involves inserting a dry needling needle near the nerve and applying electrical stimulation to reduce pain perception. Manual therapy uses digital pressure to ease muscle stiffness and pain, while exercises aim to improve jaw movement and muscle tone. Treatments occur across multiple intervention sessions. During the study, participants' pain intensity, pressure pain thresholds, and pain-free jaw opening range will be measured at each session's start and one month after the final treatment. Secondary evaluations include quality of life and muscle activation rates. The study includes assessments like physical exams and questionnaires to monitor progress and safety. Participation lasts from screening through intervention and follow-up, up to one month post-treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with local myofascial pain and/or increased tension in the masticatory muscles.
  • Diagnosed myofascial pain from temporomandibular disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
  • No temporomandibular disc displacement with or without reduction.
  • Pain in masticatory muscles with limited mouth opening less than 40 mm.
  • Good general health without chronic diseases affecting the temporomandibular joint or muscles.
  • Written consent to participate in the study.
Not Eligible

You will not qualify if you...

  • Injury to the face or head during the study participation.
  • Previous surgical procedures in the craniocervical region or degenerative neurological diseases.
  • Sudden illness that prevents study participation.
  • Desire to end participation in the study.
  • Symptoms lasting less than 2 weeks.
  • Inability to understand instructions or provide informed consent.
  • Being a minor.
  • Regular use of muscle relaxants, anticonvulsants, antidepressants, or anxiolytics.
  • Facial paralysis.
  • Presence of dental origin infections or inflammatory diseases.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration not specified

Participants receive manual therapy and exercise, with some also receiving percutaneous electrical nerve stimulation to manage pain and improve jaw function.

Multiple intervention sessions with assessments at the beginning of each session

Follow-up

Duration - 1 month after the last intervention

Participants are assessed for pain intensity, pain thresholds, jaw movement, quality of life, and muscle activation one month after the last intervention session.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Origenkinesis Fisioterapia

Alcorcón, Madrid, Spain, 28925

Actively Recruiting

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Research Team

H

Hector Mardomingo Medialdea, Phd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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