Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibu… (NCT06265636) | Clinical Trial Compass
RecruitingNot Applicable
Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders
Spain40 participantsStarted 2024-02-17
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pain intensity
Timeframe: At the beginning of each intervention session and one month after the end of the last intervention.
2
Pressure pain thresholds (PPT)
Timeframe: 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
Timeframe: At the beginning of each intervention session and one month after the end of the last intervention.