Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

NCT05006963 | Recruiting DMC

• 1 other identifier: Tele-Reabilitação em TMD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Keywords

temporomandibular joint disorders; clinical protocols; physiotherapy; remote consultation; telemedicine; telehealth; telerehabilitation; teletherapy; telepractice

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• measure Functionality

  The functionality at 12 weeks .

• measure Functionality

  The functionality at 6 months.

• Biopsychosocial analysis.

  The biopsychosocial analysis at 12 weeks .

• Biopsychosocial analysis.

  The biopsychosocial analysis at 6 months.

Study Arms (2)

face-to-face group

EXPERIMENTAL

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

telerehabilitation

ACTIVE COMPARATOR

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

Interventions

manual therapy and therapy by exercise OTHER

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.

face-to-face group; telerehabilitation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University Nove de Julho

São Paulo, 01504-001, Brazil

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, professor and researcher

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: August 16, 2021
• Study Start: September 30, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)