Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

Tele-Rehabilitation in Patients With Temporomandibular Dysfunction: Randomized, Controlled and Blind

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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Disorder
• Intervention / Treatment: Other: manual therapy and therapy by exercise

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • Recruiting
    • University Nove de Julho
    • Contact: Margarete Nobilo Leonardis, Master; Phone Number: +5511 984577584; Email: margarete.leonardis@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: face-to-face group; 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.	Other: manual therapy and therapy by exercise; 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.
Active Comparator: telerehabilitation; 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	Other: manual therapy and therapy by exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score in Numerical Pain Scale	intensity of pain	The level of pain at 12 weeks
Score in Numerical Pain Scale	intensity of pain	The level of pain at 6 months
measure range of motion	range of motion	The range of motion at range of motion at 12 weeks .
measure range of motion	range of motion	The range of motion at 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure Functionality	Mandibular Functional Limitation Questionnaire	The functionality at 12 weeks .
measure Functionality	Mandibular Functional Limitation Questionnaire	The functionality at 6 months.
Biopsychosocial analysis.	Axis II of the diagnostic criterion for temporomandibular disorders	The biopsychosocial analysis at 12 weeks .
Biopsychosocial analysis.	Axis II of the diagnostic criterion for temporomandibular disorders	The biopsychosocial analysis at 6 months.

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: telemedicine; physiotherapy; telerehabilitation; telehealth; temporomandibular joint disorders; remote consultation; clinical protocols; teletherapy; telepractice
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: Tele-Reabilitação em TMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is confidential, but if any journal requests open data for publication for sure we will provide our database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No