A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation in Patients With Myogenic Temporomandibular Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alcala
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Manual therapy and vagus nerve stimulation
Other interventionA neurodinamic intervention of vagus nerve through deep breaths involving diaphragm muscle and manual therapy techniques.
Manual therapy
Other interventionManual therapy techniques. Joint manipulation techniques for temporomandibular joints and Soft tissue techniques for the muscles
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Manual therapy and nervous vagus stimulationExperimental treatment 1 intervention
Group B: Manual therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Change from baseline at 2 months2
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.
Time frame
Change from baseline at 2 monthsSecondary outcomes
1
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.
Time frame
Change from baseline at 2 months2
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.
Time frame
Change from baseline at 2 months3
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
Time frame
Change from baseline at 2 months4
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
Time frame
Change from baseline at 2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov