Temporomandibular DisorderOrigenkineNCT06265636
Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders
A study testing Percutaneous nerve stimulation, Manual therapy and exercise in people with Temporomandibular Disorder, run by OrigenKinesis fisioterapia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Percutaneous nerve stimulation, Manual therapy and exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Minor patients.
- Regular medication, such as muscle relaxants, anticonvulsants, antidepressants, or anxiolytics
- Facial paralysis.
- Presenting a disease or infectious/inflammatory process of dental origin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Origenkinesis Fisioterapia
Alcorcón, Madrid, 28925
Hector Mardomingo Medialdea, Phd, +34 691683185, hectormardomingo@hotmail.com
About this study
Official title: Transcutaneous Mandibular Nerve Electrical Stimulation for the Management of Pain and Function in Patients With Temporomandibular Disorders
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.
Read more
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.
Read the detailed description
Pain is the most common and limiting feature of Temporomandibular Disorders (TMD), affecting approximately 75% of the population at some point in life. These disorders involve dysfunction and pain in the masticatory muscles and temporomandibular joint, impacting patients' quality of life. An estimated 60-70% of the population shows signs of TMD, with up to 12% requiring treatment. The peak incidence occurs between 20 and 40 years, predominantly affecting women (8:1 compared to men).
Temporomandibular Disorder often coexists with other medical conditions, such as headaches. The most common diagnoses are myofascial pain, followed by disc displacement with reduction and arthralgia. Prevalence ranges from 3% to 15%, with new case rates between 2% and 4%. Prognosis for myofascial TMD varies, with studies indicating persistence, remission, and relapse.
The economic cost associated with TMD is significant, with studies revealing considerable expenses on treatments. The multifactorial pathophysiology of myofascial pain is influenced by bruxism, stress, psychological conditions, and fibromyalgia. Risk factors include genetics, psychological stress, and parafunctional habits. Clinical manifestations include pain, decreased jaw mobility, and additional symptoms in the head and neck. Diagnosis involves physical examination, palpation of muscles and joints, and imaging tests such as magnetic resonance imaging. Specific diagnostic criteria have been proposed.
Conservative treatment, including physiotherapy, manual therapy, exercises, splints, and pharmacological modalities, is the primary option. However, there are limitations in the effectiveness of some approaches. Physiotherapy is considered effective by 72% of respondents in the United Kingdom.
The musculoskeletal system related to the temporomandibular joint (TMJ) consists of masticatory, facial expression, and neck muscles, playing specific roles in jaw movement. Elevator muscles (masseter, temporal, and medial pterygoid) close the mouth, depressors (digastric and lateral pterygoid) open it, protractors (temporal and lateral pterygoid) move it forward, and retractors (masseter and medial pterygoid) move it backward. Facial expression and neck muscles contribute to additional functions.
Motor innervation of the TMJ comes from the trigeminal nerve, specifically its mandibular branch (V3), which also innervates masticatory muscles. This nerve divides into branches such as the ophthalmic, maxillary, and mandibular, providing sensitivity to different areas of the face, mouth, and jaw.
Blood supply to the TMJ occurs through the superficial temporal artery and the mandibular artery, supplying blood to the skin, muscles, and surrounding joint structures.
Regarding the biomechanics and functionality of the TMJ, its complexity and crucial role in jaw movements such as chewing, speaking, and yawning are emphasized.
Manual therapy, specifically cervico-mandibular therapy, has shown significant improvements in disability related to temporomandibular disorders (TMD). The combination of manual therapy for the orofacial region and the cervical spine has proven to be more effective than home exercises or cervical treatment alone.
Therapeutic exercise in the TMJ has demonstrated moderate short-term effects and variable long-term effects in reducing pain and improving range of motion in patients with TMJ dysfunction. Passive and active stretches, as well as postural exercises, are useful for increasing range of motion and reducing pain.
Percutaneous electrical nerve stimulation (PENS) emerges as a relevant option for managing pain in TMD patients. PENS, applied through ultrasound-guided needles, can influence orofacial pain and jaw movement, offering analgesic benefits through peripheral and central mechanisms. PENS is considered a minimally invasive intervention and has been successfully used in chronic pain treatment.
In summary, a detailed understanding of the anatomy, function, innervation, and vascularization of the TMJ, combined with therapeutic approaches such as manual therapy, exercise, and PENS, is essential for comprehending and effectively addressing temporomandibular disorders.
- Conditions
- Temporomandibular Disorder
- Being tested
- Percutaneous nerve stimulation, Manual therapy, exercise
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nerve stimulationProcedure or surgery
Also called PENS
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 therapyOther
Digital pressure techniques in muscle areas with the aim of reducing the perception of stiffness and pain
exerciseOther
Exercises for improving mandibular mobility, occlusion coordination and regulation of temporomandibular muscle tone
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Manual Therapy, exercise and percutaneous electrical nerve stimulation. Receives: Procedure: Percutaneous nerve stimulation; Other: Manual therapy; Other: exercise |
| Control Group | Active comparator | Manual Therapy, exercise. Receives: Other: Manual therapy; Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: At the beginning of the first intervention and one month after the last intervention.
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).
Measured: At the beginning of the first intervention and one month after the last intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start17 Feb 2024
- Primary completion20 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrigenKinesis fisioterapia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Hector Mardomingo Medialdea, OrigenKinesis fisioterapia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265636
- Sponsor's protocol ID
- 2006202325523
- Acronym
- Origenkine
- Status last verified
- Jul 2025
- First submitted
- 16 Jan 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Mandibular Nerve Electrical Stimulation for the Management of Pain and Function in Patients With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT06265636
- Acronym / sponsor ID
- Origenkine / 2006202325523
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- OrigenKinesis fisioterapiaUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain is the most common and limiting feature of Temporomandibular Disorders (TMD), affecting approximately 75% of the population at some point in life. These disorders involve dysfunction and pain in the masticatory muscles and temporomandibular joint, impacting patients' quality of life. An estimated 60-70% of the population shows signs of TMD, with up to 12% requiring treatment. The peak incidence occurs between 20 and 40 years, predominantly affecting women (8:1 compared to men).
Temporomandibular Disorder often coexists with other medical conditions, such as headaches. The most common diagnoses are myofascial pain, followed by disc displacement with reduction and arthralgia. Prevalence ranges from 3% to 15%, with new case rates between 2% and 4%. Prognosis for myofascial TMD varies, with studies indicating persistence, remission, and relapse.
The economic cost associated with TMD is significant, with studies revealing considerable expenses on treatments. The multifactorial pathophysiology of myofascial pain is influenced by bruxism, stress, psychological conditions, and fibromyalgia. Risk factors include genetics, psychological stress, and parafunctional habits. Clinical manifestations include pain, decreased jaw mobility, and additional symptoms in the head and neck. Diagnosis involves physical examination, palpation of muscles and joints, and imaging tests such as magnetic resonance imaging. Specific diagnostic criteria have been proposed.
Conservative treatment, including physiotherapy, manual therapy, exercises, splints, and pharmacological modalities, is the primary option. However, there are limitations in the effectiveness of some approaches. Physiotherapy is considered effective by 72% of respondents in the United Kingdom.
The musculoskeletal system related to the temporomandibular joint (TMJ) consists of masticatory, facial expression, and neck muscles, playing specific roles in jaw movement. Elevator muscles (masseter, temporal, and medial pterygoid) close the mouth, depressors (digastric and lateral pterygoid) open it, protractors (temporal and lateral pterygoid) move it forward, and retractors (masseter and medial pterygoid) move it backward. Facial expression and neck muscles contribute to additional functions.
Motor innervation of the TMJ comes from the trigeminal nerve, specifically its mandibular branch (V3), which also innervates masticatory muscles. This nerve divides into branches such as the ophthalmic, maxillary, and mandibular, providing sensitivity to different areas of the face, mouth, and jaw.
Blood supply to the TMJ occurs through the superficial temporal artery and the mandibular artery, supplying blood to the skin, muscles, and surrounding joint structures.
Regarding the biomechanics and functionality of the TMJ, its complexity and crucial role in jaw movements such as chewing, speaking, and yawning are emphasized.
Manual therapy, specifically cervico-mandibular therapy, has shown significant improvements in disability related to temporomandibular disorders (TMD). The combination of manual therapy for the orofacial region and the cervical spine has proven to be more effective than home exercises or cervical treatment alone.
Therapeutic exercise in the TMJ has demonstrated moderate short-term effects and variable long-term effects in reducing pain and improving range of motion in patients with TMJ dysfunction. Passive and active stretches, as well as postural exercises, are useful for increasing range of motion and reducing pain.
Percutaneous electrical nerve stimulation (PENS) emerges as a relevant option for managing pain in TMD patients. PENS, applied through ultrasound-guided needles, can influence orofacial pain and jaw movement, offering analgesic benefits through peripheral and central mechanisms. PENS is considered a minimally invasive intervention and has been successfully used in chronic pain treatment.
In summary, a detailed understanding of the anatomy, function, innervation, and vascularization of the TMJ, combined with therapeutic approaches such as manual therapy, exercise, and PENS, is essential for comprehending and effectively addressing temporomandibular disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Percutaneous nerve stimulation, Other: Manual therapy, Other: exerciseManual Therapy, exercise and percutaneous electrical nerve stimulation. |
| Control Group | Active comparator | Other: Manual therapy, Other: exerciseManual Therapy, exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous nerve stimulationAlso: PENSPercutaneous 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. | Procedure or surgery | Experimental Group |
| Manual therapyDigital pressure techniques in muscle areas with the aim of reducing the perception of stiffness and pain | Other | Control Group, Experimental Group |
| exerciseExercises for improving mandibular mobility, occlusion coordination and regulation of temporomandibular muscle tone | Other | Control Group, Experimental Group |
Primary outcome
pain intensity
Time frame: 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)
Time frame: 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
Time frame: 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.
2 secondary outcomes
Self-reported quality of life (SF-12)
Time frame: At the beginning of the first intervention and one month after the last intervention.
Electromyographic activation rate of the masseter muscle.
Time frame: At the beginning of the first intervention and one month after the last intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous nerve stimulation, Manual therapy and exercise in people with Temporomandibular Disorder, run by OrigenKinesis fisioterapia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hector Mardomingo Medialdea, Phd (+34 691683185, hectormardomingo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: At the beginning of each intervention session and one month after the end of the last intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.