Temporomandibular Joint DisordersNCT05272488
A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation in Patients With Myogenic Temporomandibular Disorders
A study testing Manual therapy and vagus nerve stimulation and Manual therapy in people with Temporomandibular Joint Disorders and Pain, run by University of Alcala at 3 sites in Spain.
Trial summary
Temporomandibular disorders (TMD) are one of the most important Public Health issues in the world and its incidence has increased over the years. The Physiotherapy and manual therapy techniques has shown its efficacy to reduce pain and to improve jaw functionality in patients with TMD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Disorders, Pain
- What is being tested?
- Manual therapy and vagus nerve stimulation and Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Aug 2022to 15 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of myogenic pain according to the CD / TTM diagnostic criteria.
- Presence of pain during the last 30 days.
- Patients with decreased jaw function and mobility due to pain.
- Patients who have not received physiotherapy treatment in the last 3 weeks.
- Patients of legal age.
Who cannot join
- Patients with drug treatment: sedatives, anti-inflammatories, antidepressants, anxiolytics or muscle relaxants.
- Patients with cardiac pacemakers and implanted defibrillators. Patients diagnosed with severe cardiorespiratory and / or respiratory diseases, carcinogenic processes, infectious processes and / or systemic pathologies.
- Clinical diagnosis of temporomandibular disorder of joint or mixed origin according to the Diagnostic Criteria for Temporomandibular Disorders (CD / TMD).
- Patients with psychiatric or psychological disorders, intellectual or motor deficiencies that, due to their nature, prevent them from correctly performing the prescribed exercises, correctly following the physiotherapist's instructions or understanding the questionnaires and / or measurement scales of the variables.
- Patients with dental processes scheduled during the study period or who have undergone surgery in the last 3 months.
- Patients with suspicion or certainty that their pain has appeared as a consequence of a local or general trauma.
- Patients diagnosed with fibromyalgia, neuropathic pain or degenerative diseases
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Clinical University Physiotherapy and pain
Alcalá de Henares, Madrid, 2805
Patricia Martinez-Merinero, PhD, 683378391, clinica.fisio@fgua.es
- Recruiting
Martinez-Merinero, Patricia
Alcalá de Henares, Madrid, 28805
Patricia Martinez-Merinero, PhD, +34 683 37 83 91, info@institutofisioterapiaydolor.es
- Recruiting
Physioterapy and Pain center research
Alcalá de Henares, Madrid, 28805
Laura López Pérez, Mrs, +34683378391, info@institutofisioterapiaydolor.es
About this study
Official title: A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation Versus a Treatment of Manual Therapy Isolated in Patients With Myogenic Temporomandibular Disorders
Temporomandibular disorders (TMD) are one of the most important Public Health issues in the world and its incidence has increased over the years. The Physiotherapy and manual therapy techniques has shown its efficacy to reduce pain and to improve jaw functionality in patients with TMD. Until now, treatment targets has been the muscle and joint, but clinicians has not taken into account the innervation and how the nerve can have an influence in pain or jaw functionality.
In this sense, it is known that there is a relationship between jaw innervation and vagus nerve, a parasympathetic nerve which is easily stimulable, due to its connection with the respiratory system, taking deep breaths using the diaphragm.
Read more
Therefore, our hypothesis is that a treatment in which clinicians combine manual therapy and nerve vagus stimulation could have better effects (reducing pain, increasing range of motion in temporomandibular joints and improving quality of life in patients with TMD) than a isolated manual therapy treatment.
With this purpose will be selected 20 subjects to participate in our study divided in two groups. Both groups will received 4 sessions of physiotherapy (one each 7 days during one month) and also will be thought to do own treatment those days the subjects does not come to the clinic until the study will have finished (the interventional period last two months). Both groups will received the same manual therapy techniques but only the experimental group will be treated with nerve vagus stimulation technique.
One member of the group who will not participated in the interventions will be in charge of do evaluations (1 each month/ a total of 3 evaluations) following different questionaries to assess the primary variables of the study: chronic pain level, jaw functionality, physical symptoms level, range of motion and distress level.
Read the detailed description
The aim of the study is to check whether vagus nerve stimulation (VNS) combined with manual therapy (TM), given its neuroanatomical relationship with the structures involved in pain in the TMJ, is more effective in reducing pain, increasing joint range and increasing the quality ofthe patient lives than TM alone.
The research team is made up of three physiotherapists. It has been decided to distribute the tasks as follows:
- Physiotherapist 1 will be in charge of the treatment of all patients.
- Physiotherapist 2 will be responsible for screening the sample and evaluating the study.
- Physiotherapist 3 will be in charge of analyzing the results and statistics. This component of the team, being blinded and not knowing the group of origin of the patient, will be able to interpret the results without any type of convenience bias, showing absolutely transparency in the elaboration of the conclusions.
Once the screening will be completed, the patients will be divided into two groups: an experimental group (TM + ENV) and a control group (TM + ENV placebo).The randomization will be carried out through the statistical program Epidat 4,237 9 obtaining two homogeneous groups. Each patient will be assigned a code with the aim that the physiotherapist who is in charge of the statistical analysis is not able to establish links between the data and the subjects to which it refers.
- Conditions
- Temporomandibular Joint Disorders, Pain
- Being tested
- Manual therapy and vagus nerve stimulation, Manual therapy
- Keywords
- Temporomandibular Joint, Manual therapy
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy and vagus nerve stimulationOther
A neurodinamic intervention of vagus nerve through deep breaths involving diaphragm muscle and manual therapy techniques.
Manual therapyOther
Manual therapy techniques. Joint manipulation techniques for temporomandibular joints and Soft tissue techniques for the muscles
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy and nervous vagus stimulation | Experimental | Subjects will received manual therapy combined with nerve vagus stimulation. Receives: Other: Manual therapy and vagus nerve stimulation |
| Manual therapy | Active comparator | Subjects will received isolated manual therapy techniques. Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient´s state of health
An interpretation of the improvement of patient´s state of health related with temporomandibular disorders taking into account other improvements in differents areas/variables which will be described as secondary outcomes
Measured: Change from baseline at 2 months
Graded Chronic Pain Scale (CPGS)
The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. It is suitable for use in all chronic pain conditions.The 3 subscale scores (characteristic pain intensity, disability score, and the disability points score) are used to classify subjects into 1 of the 5 pain severity grades: grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting.
Measured: Change from baseline at 2 months
Secondary outcomes (4)
Range of motion (Opening without pain, Maximum Opening, Lateral movements and Protrusion movement)
All of them were measured in millimeters using a rule. The evaluator take 3 measures of each movement and the final outcome was the average of these 3 measures.
Measured: Change from baseline at 2 months
Jaw Functional Limitation Scale
The JFLS-20 is a scale that assesses the limitation of jaw function during chewing, mobility, and verbal and non-verbal communication.The maximum score is 20. Lower scores denote lower aw functional limitation and higher scores denote higher jaw functional limitation.
Measured: Change from baseline at 2 months
The Patient Health Questionnaire (PHQ-15)
The PHQ-15 is comprised of 15 items and assesses non-specific physical symptoms, also referred to as functional symptoms or medically unexplained symptoms.PHQ-15 scores of 5, 10, 15, represented cutoff points for low, medium, and high somatic symptom severity, respectively
Measured: Change from baseline at 2 months
Distress Level PHQ-4
This one was assesed using PHQ-4. The PHQ-4 is comprised of two 2-item subscales, anxiety and depression, and it is intended to be an ultrabrief screener for distress as the composite construct of anxiety and depression.Total scores range from 0 to 12, with higher scores indicating greater psychological distress
Measured: Change from baseline at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Aug 2022
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Alejandro Ferragut-Garcías, PhD, Study chair, Universidad Islas Baleares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272488
- Sponsor's protocol ID
- CEIM/2021/6/144
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2021
- Last updated
- 1 May 2026
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation Versus a Treatment of Manual Therapy Isolated in Patients With Myogenic Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT05272488
- Acronym / sponsor ID
- CEIM/2021/6/144
- Conditions
- Temporomandibular Joint Disorders, Pain
- Keywords
- Temporomandibular Joint, Manual therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 9 Mar 2022 (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) are one of the most important Public Health issues in the world and its incidence has increased over the years. The Physiotherapy and manual therapy techniques has shown its efficacy to reduce pain and to improve jaw functionality in patients with TMD. Until now, treatment targets has been the muscle and joint, but clinicians has not taken into account the innervation and how the nerve can have an influence in pain or jaw functionality.
In this sense, it is known that there is a relationship between jaw innervation and vagus nerve, a parasympathetic nerve which is easily stimulable, due to its connection with the respiratory system, taking deep breaths using the diaphragm.
Therefore, our hypothesis is that a treatment in which clinicians combine manual therapy and nerve vagus stimulation could have better effects (reducing pain, increasing range of motion in temporomandibular joints and improving quality of life in patients with TMD) than a isolated manual therapy treatment.
With this purpose will be selected 20 subjects to participate in our study divided in two groups. Both groups will received 4 sessions of physiotherapy (one each 7 days during one month) and also will be thought to do own treatment those days the subjects does not come to the clinic until the study will have finished (the interventional period last two months). Both groups will received the same manual therapy techniques but only the experimental group will be treated with nerve vagus stimulation technique.
One member of the group who will not participated in the interventions will be in charge of do evaluations (1 each month/ a total of 3 evaluations) following different questionaries to assess the primary variables of the study: chronic pain level, jaw functionality, physical symptoms level, range of motion and distress level.
Detailed description
The aim of the study is to check whether vagus nerve stimulation (VNS) combined with manual therapy (TM), given its neuroanatomical relationship with the structures involved in pain in the TMJ, is more effective in reducing pain, increasing joint range and increasing the quality ofthe patient lives than TM alone.
The research team is made up of three physiotherapists. It has been decided to distribute the tasks as follows:
- Physiotherapist 1 will be in charge of the treatment of all patients.
- Physiotherapist 2 will be responsible for screening the sample and evaluating the study.
- Physiotherapist 3 will be in charge of analyzing the results and statistics. This component of the team, being blinded and not knowing the group of origin of the patient, will be able to interpret the results without any type of convenience bias, showing absolutely transparency in the elaboration of the conclusions.
Once the screening will be completed, the patients will be divided into two groups: an experimental group (TM + ENV) and a control group (TM + ENV placebo).The randomization will be carried out through the statistical program Epidat 4,237 9 obtaining two homogeneous groups. Each patient will be assigned a code with the aim that the physiotherapist who is in charge of the statistical analysis is not able to establish links between the data and the subjects to which it refers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy and nervous vagus stimulation | Experimental | Other: Manual therapy and vagus nerve stimulationSubjects will received manual therapy combined with nerve vagus stimulation. |
| Manual therapy | Active comparator | Other: Manual therapySubjects will received isolated manual therapy techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of myogenic pain according to the CD / TTM diagnostic criteria.
- Presence of pain during the last 30 days.
- Patients with decreased jaw function and mobility due to pain.
- Patients who have not received physiotherapy treatment in the last 3 weeks.
- Patients of legal age.
Key exclusion criteria (7 listed)
- Patients with drug treatment: sedatives, anti-inflammatories, antidepressants, anxiolytics or muscle relaxants.
- Patients with cardiac pacemakers and implanted defibrillators. Patients diagnosed with severe cardiorespiratory and / or respiratory diseases, carcinogenic processes, infectious processes and / or systemic pathologies.
- Clinical diagnosis of temporomandibular disorder of joint or mixed origin according to the Diagnostic Criteria for Temporomandibular Disorders (CD / TMD).
- Patients with psychiatric or psychological disorders, intellectual or motor deficiencies that, due to their nature, prevent them from correctly performing the prescribed exercises, correctly following the physiotherapist's instructions or understanding the questionnaires and / or measurement scales of the variables.
- Patients with dental processes scheduled during the study period or who have undergone surgery in the last 3 months.
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 |
|---|---|---|
| Manual therapy and vagus nerve stimulationA neurodinamic intervention of vagus nerve through deep breaths involving diaphragm muscle and manual therapy techniques. | Other | Manual therapy and nervous vagus stimulation |
| Manual therapyManual therapy techniques. Joint manipulation techniques for temporomandibular joints and Soft tissue techniques for the muscles | Other | Manual therapy |
Primary outcome
Patient´s state of health
Time frame: Change from baseline at 2 months
An interpretation of the improvement of patient´s state of health related with temporomandibular disorders taking into account other improvements in differents areas/variables which will be described as secondary outcomes
Graded Chronic Pain Scale (CPGS)
Time frame: Change from baseline at 2 months
The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. It is suitable for use in all chronic pain conditions.The 3 subscale scores (characteristic pain intensity, disability score, and the disability points score) are used to classify subjects into 1 of the 5 pain severity grades: grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting.
4 secondary outcomes
Range of motion (Opening without pain, Maximum Opening, Lateral movements and Protrusion movement)
Time frame: Change from baseline at 2 months
Jaw Functional Limitation Scale
Time frame: Change from baseline at 2 months
The Patient Health Questionnaire (PHQ-15)
Time frame: Change from baseline at 2 months
Distress Level PHQ-4
Time frame: Change from baseline at 2 months
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 1 May 2026.
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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.
Alejandro Ferragut-Garcías, PhD study chair
Universidad Islas Baleares
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and vagus nerve stimulation and Manual therapy in people with Temporomandibular Joint Disorders and Pain, run by University of Alcala at 3 sites 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 5 inclusion and 7 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Patricia Martinez-Merinero, PhD (+34 683 378 391, info@institutofisioterapiaydolor.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient´s state of health (time frame: Change from baseline at 2 months). The study lists 2 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 1 May 2026.