<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477122</url>
  </required_header>
  <id_info>
    <org_study_id>UJaen Posture</org_study_id>
    <nct_id>NCT04477122</nct_id>
  </id_info>
  <brief_title>Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome.</brief_title>
  <official_title>Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome. A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jaén</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jaén</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the effects of radial shock wave therapy in the treatment&#xD;
      of temporomandibular joint syndrome. For this objective, subjects recruited will be allocated&#xD;
      in an experimental group or a placebo group. Both groups will receive one manual therapy and&#xD;
      radial shock waves therapy (real for experimental group, a sham device for placebo group)&#xD;
      session per week along one month. Pain, neck function and quality of life measured will be&#xD;
      performed before the intervention, after the last treatment and at one month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Temporomandibular Disorders (TMDs) are a subgroup of painful orofacial disorders of the&#xD;
      stomatognathic system, characterized by TemporoMandibular Joint (TMJ) pain, fatigue of the&#xD;
      cranio-cervico-facial muscles (especially the masticatory muscles), limitation of mandibular&#xD;
      movement and the presence of a click or crackling sound in the ATM.&#xD;
&#xD;
      The main signs and symptoms associated with TMDs are bruxism (33%), myofascial pain (14%),&#xD;
      headache (96%) and functional limitation (93%), the latter being related to posture.&#xD;
&#xD;
      The quality of life of patients with TMD involvement is diminished in various facets of their&#xD;
      lives, leading to a private expense for the patient as well as a public expense resulting&#xD;
      from a poor referral due to the lack of adequate treatment for TMDs. This expense ranges in&#xD;
      Spanish public hospitals at € 146.9 with a minimum of € 52 and a maximum of € 425.&#xD;
&#xD;
      From this study, we are going to carry out a non-invasive, analgesic, anti-inflammatory&#xD;
      treatment and without negative side effects for the patient through radial extracorporeal&#xD;
      shock waves (rESWT), and manual therapy (TM).&#xD;
&#xD;
      Among the effects produced by shock waves we find that they improve circulation due to&#xD;
      increased blood flow and oxygenation, at tissue level the permeability of the membrane&#xD;
      increases and its metabolic process, therefore facilitating the activation of tissue&#xD;
      regeneration processes experiencing dystrophic changes. Furthermore, shock waves cause&#xD;
      anti-inflammatory effects and muscle relaxation.&#xD;
&#xD;
      The main objective of the study is to evaluate the capacity of the shock waves to improve the&#xD;
      alterations due to temporomandibular disorders. To meet the above objective, a single-blind&#xD;
      randomized clinical trial study has been designed. The selected subjects will be of legal age&#xD;
      diagnosed with temporomandibular disorder and those subjects that due to their own&#xD;
      characteristics are not able to carry out the study will be excluded. Subjects will receive a&#xD;
      weekly physical therapy session for four weeks. Subjects will be randomly assigned to two&#xD;
      groups: T1 intervention group consisting of subjects who will receive manual therapy&#xD;
      treatment and shock waves and T2 placebo group in which the subjects will receive manual&#xD;
      therapy and placebo shock waves.&#xD;
&#xD;
      Subjects will be evaluated using sociodemographic variables such as age, sex, weight, height,&#xD;
      Body Mass Index, educational level, work, smoking, alcohol and physical activity and function&#xD;
      tests and quality of life questionnaires will be used. Measurements will be made pre and&#xD;
      post-treatment, one month after the last evaluation, the measurements will be made again for&#xD;
      follow-up. The intervention will be one day a week for four consecutive weeks.&#xD;
&#xD;
      The data will be collected using a self-implementing questionnaire, these data will be&#xD;
      transferred to an excel table and then transferred to SPSS 19.0 (SPSS Inc., Chicago, IL) and&#xD;
      MedCalc 19.1 (MedCalc Software Bv, Ostend, Belgium, http: // wwww .medcalc.org; 2019) for the&#xD;
      subsequent statistical analysis, the data being stripped of any direct reference to the&#xD;
      subject to preserve confidentiality.&#xD;
&#xD;
      The descriptive analysis will be carried out with means and standard deviations for&#xD;
      continuous variables, frequencies and percentages for categorical variables. The normality of&#xD;
      the continuous variables will be calculated with the Kolmogorov-Smirnov test and the&#xD;
      homocedasticity of the sample with the Levene test.&#xD;
&#xD;
      All the statistical analysis will be carried out with a confidence level of 95% (p &lt;0.05),&#xD;
      for the comparison of the two groups we will use the Student's t-test and the Chi-square&#xD;
      test. Comparisons between treatment group and placebo group will be made using repeated&#xD;
      measures analysis of variance and ANOVA, followed by Bonferroni to compare measures&#xD;
      replicated over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2020</start_date>
  <completion_date type="Actual">January 25, 2021</completion_date>
  <primary_completion_date type="Actual">December 29, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two groups: experimental one and placebo group, receiving the intervention at the same time</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants will take and opaque enveloped who revealed the allocation group (named as RED or BLUE for blindness conditions). Investigators will not be aware of the which device is sham or real treatment due to codification. The outcomes assessor will be a different person from the investigator and the care providers, unaware of group allocation and treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Temporomandibular joint pain</measure>
    <time_frame>Baseline</time_frame>
    <description>Actual local pain at temporomandibular joint measured with Numerical pain rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temporomandibular joint pain</measure>
    <time_frame>At one month</time_frame>
    <description>Actual local pain at temporomandibular joint measured with Numerical pain rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temporomandibular joint pain Temporomandibular joint pain</measure>
    <time_frame>At two months</time_frame>
    <description>Actual local pain at temporomandibular joint measured with Numerical pain rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck function</measure>
    <time_frame>Baseline</time_frame>
    <description>Neck Disability Index, a 10 questions scale about neck function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck function</measure>
    <time_frame>At one month</time_frame>
    <description>Neck Disability Index, a 10 questions scale about neck function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck function</measure>
    <time_frame>At two months</time_frame>
    <description>Neck Disability Index, a 10 questions scale about neck function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain threshold</measure>
    <time_frame>Baseline</time_frame>
    <description>Beginning of pain feeling referred at pressure with algometer at temporomandibular joint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain threshold</measure>
    <time_frame>At one month</time_frame>
    <description>Beginning of pain feeling referred at pressure with algometer at temporomandibular joint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain threshold</measure>
    <time_frame>At two months</time_frame>
    <description>Beginning of pain feeling referred at pressure with algometer at temporomandibular joint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache impact in quality of life</measure>
    <time_frame>Baseline</time_frame>
    <description>Headache Impact Test (HIT-6) consisting on six questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache impact in quality of life</measure>
    <time_frame>At one month</time_frame>
    <description>Headache Impact Test (HIT-6) consisting on six questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache impact in quality of life</measure>
    <time_frame>At two months</time_frame>
    <description>Headache Impact Test (HIT-6) consisting on six questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness</measure>
    <time_frame>Baseline</time_frame>
    <description>Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness</measure>
    <time_frame>At one month</time_frame>
    <description>Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness</measure>
    <time_frame>At two months</time_frame>
    <description>Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life Measured with SF-12</measure>
    <time_frame>Baseline</time_frame>
    <description>12 questions about quality of life perceived</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life Measured with SF-12</measure>
    <time_frame>At one month</time_frame>
    <description>12 questions about quality of life perceived</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life Measured with SF-12</measure>
    <time_frame>At two months</time_frame>
    <description>12 questions about quality of life perceived</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular joint function</measure>
    <time_frame>Baseline</time_frame>
    <description>Fonseca Anamnesis Index, 10 questions about temporomandibular joint function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular joint function</measure>
    <time_frame>At one month</time_frame>
    <description>Fonseca Anamnesis Index, 10 questions about temporomandibular joint function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular joint function</measure>
    <time_frame>At two months</time_frame>
    <description>Fonseca Anamnesis Index, 10 questions about temporomandibular joint function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular joint function</measure>
    <time_frame>Baseline</time_frame>
    <description>Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular joint function</measure>
    <time_frame>At one month</time_frame>
    <description>Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular joint function</measure>
    <time_frame>At two months</time_frame>
    <description>Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Temporomandibular Joint Disorders</condition>
  <condition>Temporomandibular Joint Dysfunction Syndrome</condition>
  <arm_group>
    <arm_group_label>Blue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four sessions (one per week along one month) of manual therapy (25 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes (2000 shots approximately) of extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles at 2 bars and 10 Hertzs. Participants will wear splint 23 hours/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Red</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Four sessions (one per week along one month) of manual therapy (25 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes of placebo extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles. Participants will wear splint 23 hours/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual therapy and extracorporeal radial shock waves therapy</intervention_name>
    <description>25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)</description>
    <arm_group_label>Blue</arm_group_label>
    <arm_group_label>Red</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed of temporomandibular disorder by medical doctor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who due to their own characteristics are not able to carry out the study&#xD;
             tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinica Fisiomedic</name>
      <address>
        <city>Sevilla</city>
        <zip>41000</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jaén</investigator_affiliation>
    <investigator_full_name>Alfonso Javier Ibáñez-Vera</investigator_full_name>
    <investigator_title>Health Sciences Department Professor</investigator_title>
  </responsible_party>
  <keyword>temporomandibular joint</keyword>
  <keyword>temporomandibular joint syndrome</keyword>
  <keyword>temporomandibular joint dysfunction</keyword>
  <keyword>extracorporeal shock waves</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be available under request to the authors/promotor</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477122
org study id: UJaen Posture
nct id: NCT04477122
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this study is to assess the effects of radial shock wave therapy in the treatment
      of temporomandibular joint syndrome. For this objective, subjects recruited will be allocated
      in an experimental group or a placebo group. Both groups will receive one manual therapy and
      radial shock waves therapy (real for experimental group, a sham device for placebo group)
      session per week along one month. Pain, neck function and quality of life measured will be
      performed before the intervention, after the last treatment and at one month follow-up.
Temporomandibular Disorders (TMDs) are a subgroup of painful orofacial disorders of the
      stomatognathic system, characterized by TemporoMandibular Joint (TMJ) pain, fatigue of the
      cranio-cervico-facial muscles (especially the masticatory muscles), limitation of mandibular
      movement and the presence of a click or crackling sound in the ATM.

      The main signs and symptoms associated with TMDs are bruxism (33%), myofascial pain (14%),
      headache (96%) and functional limitation (93%), the latter being related to posture.

      The quality of life of patients with TMD involvement is diminished in various facets of their
      lives, leading to a private expense for the patient as well as a public expense resulting
      from a poor referral due to the lack of adequate treatment for TMDs. This expense ranges in
      Spanish public hospitals at € 146.9 with a minimum of € 52 and a maximum of € 425.

      From this study, we are going to carry out a non-invasive, analgesic, anti-inflammatory
      treatment and without negative side effects for the patient through radial extracorporeal
      shock waves (rESWT), and manual therapy (TM).

      Among the effects produced by shock waves we find that they improve circulation due to
      increased blood flow and oxygenation, at tissue level the permeability of the membrane
      increases and its metabolic process, therefore facilitating the activation of tissue
      regeneration processes experiencing dystrophic changes. Furthermore, shock waves cause
      anti-inflammatory effects and muscle relaxation.

      The main objective of the study is to evaluate the capacity of the shock waves to improve the
      alterations due to temporomandibular disorders. To meet the above objective, a single-blind
      randomized clinical trial study has been designed. The selected subjects will be of legal age
      diagnosed with temporomandibular disorder and those subjects that due to their own
      characteristics are not able to carry out the study will be excluded. Subjects will receive a
      weekly physical therapy session for four weeks. Subjects will be randomly assigned to two
      groups: T1 intervention group consisting of subjects who will receive manual therapy
      treatment and shock waves and T2 placebo group in which the subjects will receive manual
      therapy and placebo shock waves.

      Subjects will be evaluated using sociodemographic variables such as age, sex, weight, height,
      Body Mass Index, educational level, work, smoking, alcohol and physical activity and function
      tests and quality of life questionnaires will be used. Measurements will be made pre and
      post-treatment, one month after the last evaluation, the measurements will be made again for
      follow-up. The intervention will be one day a week for four consecutive weeks.

      The data will be collected using a self-implementing questionnaire, these data will be
      transferred to an excel table and then transferred to SPSS 19.0 (SPSS Inc., Chicago, IL) and
      MedCalc 19.1 (MedCalc Software Bv, Ostend, Belgium, http: // wwww .medcalc.org; 2019) for the
      subsequent statistical analysis, the data being stripped of any direct reference to the
      subject to preserve confidentiality.

      The descriptive analysis will be carried out with means and standard deviations for
      continuous variables, frequencies and percentages for categorical variables. The normality of
      the continuous variables will be calculated with the Kolmogorov-Smirnov test and the
      homocedasticity of the sample with the Levene test.

      All the statistical analysis will be carried out with a confidence level of 95% (p <0.05),
      for the comparison of the two groups we will use the Student's t-test and the Chi-square
      test. Comparisons between treatment group and placebo group will be made using repeated
      measures analysis of variance and ANOVA, followed by Bonferroni to compare measures
      replicated over time.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups: experimental one and placebo group, receiving the intervention at the same time
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Participants will take and opaque enveloped who revealed the allocation group (named as RED or BLUE for blindness conditions). Investigators will not be aware of the which device is sham or real treatment due to codification. The outcomes assessor will be a different person from the investigator and the care providers, unaware of group allocation and treatment.
measure: Temporomandibular joint pain
time frame: Baseline
description: Actual local pain at temporomandibular joint measured with Numerical pain rating scale
measure: Temporomandibular joint pain
time frame: At one month
description: Actual local pain at temporomandibular joint measured with Numerical pain rating scale
measure: Temporomandibular joint pain Temporomandibular joint pain
time frame: At two months
description: Actual local pain at temporomandibular joint measured with Numerical pain rating scale
measure: Neck function
time frame: Baseline
description: Neck Disability Index, a 10 questions scale about neck function
measure: Neck function
time frame: At one month
description: Neck Disability Index, a 10 questions scale about neck function
measure: Neck function
time frame: At two months
description: Neck Disability Index, a 10 questions scale about neck function
measure: Pain threshold
time frame: Baseline
description: Beginning of pain feeling referred at pressure with algometer at temporomandibular joint
measure: Pain threshold
time frame: At one month
description: Beginning of pain feeling referred at pressure with algometer at temporomandibular joint
measure: Pain threshold
time frame: At two months
description: Beginning of pain feeling referred at pressure with algometer at temporomandibular joint
measure: Headache impact in quality of life
time frame: Baseline
description: Headache Impact Test (HIT-6) consisting on six questions
measure: Headache impact in quality of life
time frame: At one month
description: Headache Impact Test (HIT-6) consisting on six questions
measure: Headache impact in quality of life
time frame: At two months
description: Headache Impact Test (HIT-6) consisting on six questions
measure: Dizziness
time frame: Baseline
description: Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life
measure: Dizziness
time frame: At one month
description: Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life
measure: Dizziness
time frame: At two months
description: Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life
measure: Quality of life Measured with SF-12
time frame: Baseline
description: 12 questions about quality of life perceived
measure: Quality of life Measured with SF-12
time frame: At one month
description: 12 questions about quality of life perceived
measure: Quality of life Measured with SF-12
time frame: At two months
description: 12 questions about quality of life perceived
measure: Temporomandibular joint function
time frame: Baseline
description: Fonseca Anamnesis Index, 10 questions about temporomandibular joint function
measure: Temporomandibular joint function
time frame: At one month
description: Fonseca Anamnesis Index, 10 questions about temporomandibular joint function
measure: Temporomandibular joint function
time frame: At two months
description: Fonseca Anamnesis Index, 10 questions about temporomandibular joint function
measure: Temporomandibular joint function
time frame: Baseline
description: Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function
measure: Temporomandibular joint function
time frame: At one month
description: Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function
measure: Temporomandibular joint function
time frame: At two months
description: Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function
arm group label: Blue
arm group type: Experimental
description: Four sessions (one per week along one month) of manual therapy (25 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes (2000 shots approximately) of extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles at 2 bars and 10 Hertzs. Participants will wear splint 23 hours/day
arm group label: Red
arm group type: Placebo Comparator
description: Four sessions (one per week along one month) of manual therapy (25 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes of placebo extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles. Participants will wear splint 23 hours/day
intervention type: Other
intervention name: Manual therapy and extracorporeal radial shock waves therapy
description: 25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)
arm group label: Blue
arm group label: Red
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Jaén
investigator full name: Alfonso Javier Ibáñez-Vera
investigator title: Health Sciences Department Professor
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Syndrome
sharing ipd: No
ipd description: Data will be available under request to the authors/promotor