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Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

Primary Purpose

Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
manual therapy and therapy by exercise
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring temporomandibular joint disorders, clinical protocols, physiotherapy, remote consultation, telemedicine, telehealth, telerehabilitation, teletherapy, telepractice

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers
  1. Age between 18 and 60 years;
  2. presence of pain in the facial region in the last 6 months;
  3. diagnosis of myalgia, arthralgia, headache attributed to temporomandibular disfunction and/or subluxation temporomandibular joint.

Sites / Locations

  • University Nove de JulhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

face-to-face group

telerehabilitation

Arm Description

The patient will be submitted to multimodal treatment, twice a week, for twelve weeks, totaling 24 face-to-face consultations lasting 40 minutes each. In the first session, the patient will be explained what is TMD, what is the correct placement of the tongue and teeth, influence of parafunctional and sleep habits in TMD signs and symptoms.Techniques of manual therapy and therapy by exercise. In general, extra-oral and intraoral massage, myofascial release in the cranio-cervical musculature, mobilization of the hyoid bone and may also receive unspecific joint mobilization. Will be mouth opening exercise will be also performed with the tongue on the palate, proprioceptive exercises with hyperboloid. In addition to these, additional exercises may be performed, according to the patient's need. The conducts will be adapted according to the needs of each patient. The use of post its may be indicated to help maintain the correct posture of the tongue and jaw, as well as sleep hygiene.

The patient will be submitted to multimodal treatment, twice a week, for twelve weeks, by telerehabilitation lasting 40 minutes each.A physiotherapist through video call via WhatsApp application. In the first session, the patient will be explained what is TMD, what is the correct placement of the tongue and teeth, influence of parafunctional and sleep habits in TMD signs and symptoms. Patients will be instructed to perform extra-oral and intra-oral self-massage and in the cranio-cervical musculature, bone mobilization hyoid, which would replace the mobilization unspecific articulation performed in person.Exercise will also be carried out mouth opening with tongue on the palate, exercises proprioceptives with hyperboloid. The conducts will be adapted according to the needs of each patient.The conducts will be adapted according to the needs of each patient.The use of post its may be indicated to help maintain the correct posture of the tongue and jaw, as well as sleep hygiene

Outcomes

Primary Outcome Measures

Score in Numerical Pain Scale
intensity of pain
Score in Numerical Pain Scale
intensity of pain
measure range of motion
range of motion
measure range of motion
range of motion

Secondary Outcome Measures

measure Functionality
Mandibular Functional Limitation Questionnaire
measure Functionality
Mandibular Functional Limitation Questionnaire
Biopsychosocial analysis.
Axis II of the diagnostic criterion for temporomandibular disorders
Biopsychosocial analysis.
Axis II of the diagnostic criterion for temporomandibular disorders

Full Information

First Posted
November 26, 2020
Last Updated
February 14, 2023
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05006963
Brief Title
Tele-Rehabilitation in Patients With Temporomandibular Dysfunction
Official Title
Tele-Rehabilitation in Patients With Temporomandibular Dysfunction: Randomized, Controlled and Blind
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

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

5. Study Description

Brief Summary
Temporomandibular disorder or TMD is characterized by a set of symptoms such as: pain, decreased range of motion and joint noise. It's origin is multifactorial, which may be related to biological aspects, environmental and psychosocial. The multimodal approach has been widely used in physiotherapy for the treatment of TMDs. Physiotherapy has been walking together with technology so that telerehabilitation can be a reality, contributing so that quality care reaches the patient, in the impossibility office-to-face service. The objective of this study is to verify the effect of telerehabilitation on pain outcomes, range of motion, functionality and biopsychosocial aspects in individuals with temporomandibular disorders. Will be a randomized, controlled and blinded clinical trial was carried out. The study will be divided into two moments: evaluation and intervention. Evaluations will be carried out using the Diagnostic Criteria for Temporomandibular Disorders: Clinical Protocol and Assessment Instruments (DC/TMD), the Fonseca Anamnesis Index (IAF), the Numerical Pain Scale (END) and the Functional Limitation Questionnaire (MFIQ). Individuals will be randomized into 2 groups: Group A (in person) Group B (telerehabilitation). Both groups will receive treatment physical therapy for 12 weeks. After collecting the data, they will be tabulated and analyzed using a 5% significance level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
Keywords
temporomandibular joint disorders, clinical protocols, physiotherapy, remote consultation, telemedicine, telehealth, telerehabilitation, teletherapy, telepractice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Two researchers will be part of the protocol. One will be responsible for pre and post intervention assessments and will be blind to the type of intervention. The other will be responsible for the treatment phase: face-to-face and telerehabilitation. A third party collaborator will process and statistically analyze the collected data. Individuals will be randomized using the statistical program present at www.randomization.com , in two groups. Randomization and concealment of allocation will be made by a fourth external employee, not research participant, who will organize the allocation in individual opaque envelopesand keep it confidential. There will be 2 blocks of 25 envelopes: face-to-face (GA) and telerehabilitation (GB). With this process, participants will have the same probability of being allocated to one of the two treatment groups. Blinding of the evaluator will be maintained until the end of the research and data tabulation.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
face-to-face group
Arm Type
Experimental
Arm Description
The patient will be submitted to multimodal treatment, twice a week, for twelve weeks, totaling 24 face-to-face consultations lasting 40 minutes each. In the first session, the patient will be explained what is TMD, what is the correct placement of the tongue and teeth, influence of parafunctional and sleep habits in TMD signs and symptoms.Techniques of manual therapy and therapy by exercise. In general, extra-oral and intraoral massage, myofascial release in the cranio-cervical musculature, mobilization of the hyoid bone and may also receive unspecific joint mobilization. Will be mouth opening exercise will be also performed with the tongue on the palate, proprioceptive exercises with hyperboloid. In addition to these, additional exercises may be performed, according to the patient's need. The conducts will be adapted according to the needs of each patient. The use of post its may be indicated to help maintain the correct posture of the tongue and jaw, as well as sleep hygiene.
Arm Title
telerehabilitation
Arm Type
Active Comparator
Arm Description
The patient will be submitted to multimodal treatment, twice a week, for twelve weeks, by telerehabilitation lasting 40 minutes each.A physiotherapist through video call via WhatsApp application. In the first session, the patient will be explained what is TMD, what is the correct placement of the tongue and teeth, influence of parafunctional and sleep habits in TMD signs and symptoms. Patients will be instructed to perform extra-oral and intra-oral self-massage and in the cranio-cervical musculature, bone mobilization hyoid, which would replace the mobilization unspecific articulation performed in person.Exercise will also be carried out mouth opening with tongue on the palate, exercises proprioceptives with hyperboloid. The conducts will be adapted according to the needs of each patient.The conducts will be adapted according to the needs of each patient.The use of post its may be indicated to help maintain the correct posture of the tongue and jaw, as well as sleep hygiene
Intervention Type
Other
Intervention Name(s)
manual therapy and therapy by exercise
Intervention Description
In general, patients will receive extra-oral massage and intraoral massage, myofascial release in the cranio-cervical musculature, mobilization of the hyoid bone and may also receive unspecific joint mobilization. Will bemouth opening exercise was also performed with the tongue on the palate, proprioceptive lateralization and protrusion exercises with hyperboloid and exercises with combinations of movements of laterality and opening, or protrusion and opening.
Primary Outcome Measure Information:
Title
Score in Numerical Pain Scale
Description
intensity of pain
Time Frame
The level of pain at 12 weeks
Title
Score in Numerical Pain Scale
Description
intensity of pain
Time Frame
The level of pain at 6 months
Title
measure range of motion
Description
range of motion
Time Frame
The range of motion at range of motion at 12 weeks .
Title
measure range of motion
Description
range of motion
Time Frame
The range of motion at 6 months.
Secondary Outcome Measure Information:
Title
measure Functionality
Description
Mandibular Functional Limitation Questionnaire
Time Frame
The functionality at 12 weeks .
Title
measure Functionality
Description
Mandibular Functional Limitation Questionnaire
Time Frame
The functionality at 6 months.
Title
Biopsychosocial analysis.
Description
Axis II of the diagnostic criterion for temporomandibular disorders
Time Frame
The biopsychosocial analysis at 12 weeks .
Title
Biopsychosocial analysis.
Description
Axis II of the diagnostic criterion for temporomandibular disorders
Time Frame
The biopsychosocial analysis at 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Age between 18 and 60 years; presence of pain in the facial region in the last 6 months; diagnosis of myalgia, arthralgia, headache attributed to temporomandibular disfunction and/or subluxation temporomandibular joint.
Facility Information:
Facility Name
University Nove de Julho
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarete Nobilo Leonardis, Master
Phone
+5511 984577584
Email
margarete.leonardis@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data is confidential, but if any journal requests open data for publication for sure we will provide our database

Learn more about this trial

Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

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