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NCT Number: NCT05006963

Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Nove de Julho

São Paulo, 01504-001, Brazil

Location status: Recruiting

Location contact

Margarete Nobilo Leonardis, Master

CONTACT

[email protected]

+5511 984577584

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Score in Numerical Pain Scale

    Time frame: The level of pain at 12 weeks

    intensity of pain

  2. Score in Numerical Pain Scale

    Time frame: The level of pain at 6 months

    intensity of pain

  3. measure range of motion

    Time frame: The range of motion at range of motion at 12 weeks .

    range of motion

  4. measure range of motion

    Time frame: The range of motion at 6 months.

    range of motion

Secondary outcomes

  1. measure Functionality

    Time frame: The functionality at 12 weeks .

    Mandibular Functional Limitation Questionnaire

  2. measure Functionality

    Time frame: The functionality at 6 months.

    Mandibular Functional Limitation Questionnaire

  3. Biopsychosocial analysis.

    Time frame: The biopsychosocial analysis at 12 weeks .

    Axis II of the diagnostic criterion for temporomandibular disorders

  4. Biopsychosocial analysis.

    Time frame: The biopsychosocial analysis at 6 months.

    Axis II of the diagnostic criterion for temporomandibular disorders

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 16, 2021
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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