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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual therapy and nervous vagus stimulation | Experimental | Subjects will received manual therapy combined with nerve vagus stimulation. |
|
| Manual therapy | Active Comparator | Subjects will received isolated manual therapy techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual therapy and vagus nerve stimulation | Other | A neurodinamic intervention of vagus nerve through deep breaths involving diaphragm muscle and manual therapy techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Change from baseline at 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline at 2 months |
| Jaw Functional Limitation Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Martinez-Merinero, PhD | Contact | +34 683 378 391 | info@institutofisioterapiaydolor.es | |
| Daniel Pecos-Martin, PhD | Contact | +34 9188551442 | daniel.pecos@uah.es |
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Ferragut-Garcías, PhD | Universidad Islas Baleares | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical University Physiotherapy and pain | Recruiting | Alcalá de Henares | Madrid | 2805 | Spain |
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| Manual therapy | Other | Manual therapy techniques. Joint manipulation techniques for temporomandibular joints and Soft tissue techniques for the muscles |
|
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. |
| 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 | 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 | Change from baseline at 2 months |
| Martinez-Merinero, Patricia | Recruiting | Alcalá de Henares | Madrid | 28805 | Spain |
|
| Physioterapy and Pain center research | Recruiting | Alcalá de Henares | Madrid | 28805 | Spain |
|
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004599 | Electric Stimulation Therapy |
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