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A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation in Patients With Myogenic Temporomandibular Disorders

Primary Purpose

Temporomandibular Joint Disorders, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy and vagus nerve stimulation
Manual therapy
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular Joint, Manual therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Clinical University Physiotherapy and painRecruiting
  • Martinez-Merinero, PatriciaRecruiting
  • Physioterapy and Pain center researchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual therapy and nervous vagus stimulation

Manual therapy

Arm Description

Subjects will received manual therapy combined with nerve vagus stimulation.

Subjects will received isolated manual therapy techniques.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
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
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

Full Information

First Posted
November 17, 2021
Last Updated
October 24, 2023
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT05272488
Brief Title
A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation in Patients With Myogenic Temporomandibular Disorders
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Pain
Keywords
Temporomandibular Joint, Manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy and nervous vagus stimulation
Arm Type
Experimental
Arm Description
Subjects will received manual therapy combined with nerve vagus stimulation.
Arm Title
Manual therapy
Arm Type
Active Comparator
Arm Description
Subjects will received isolated manual therapy techniques.
Intervention Type
Other
Intervention Name(s)
Manual therapy and vagus nerve stimulation
Intervention Description
A neurodinamic intervention of vagus nerve through deep breaths involving diaphragm muscle and manual therapy techniques.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
Manual therapy techniques. Joint manipulation techniques for temporomandibular joints and Soft tissue techniques for the muscles
Primary Outcome Measure Information:
Title
Patient´s state of health
Description
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 months
Title
Graded Chronic Pain Scale (CPGS)
Description
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 months
Secondary Outcome Measure Information:
Title
Range of motion (Opening without pain, Maximum Opening, Lateral movements and Protrusion movement)
Description
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 months
Title
Jaw Functional Limitation Scale
Description
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 months
Title
The Patient Health Questionnaire (PHQ-15)
Description
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 months
Title
Distress Level PHQ-4
Description
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 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Martinez-Merinero, PhD
Phone
+34 683 378 391
Email
info@institutofisioterapiaydolor.es
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Pecos-Martin, PhD
Phone
+34 9188551442
Email
daniel.pecos@uah.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Ferragut-Garcías, PhD
Organizational Affiliation
Universidad Islas Baleares
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical University Physiotherapy and pain
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
2805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Martinez-Merinero, PhD
Phone
683378391
Email
clinica.fisio@fgua.es
Facility Name
Martinez-Merinero, Patricia
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Martinez-Merinero, PhD
Phone
+34 683 37 83 91
Email
info@institutofisioterapiaydolor.es
Facility Name
Physioterapy and Pain center research
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura López Pérez, Mrs
Phone
+34683378391
Email
info@institutofisioterapiaydolor.es

12. IPD Sharing Statement

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A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation in Patients With Myogenic Temporomandibular Disorders

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