Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006963
• Other study ID #: Tele-Reabilitação em TMD
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.

Locations

Country	Name	City	State
Brazil	University Nove de Julho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score in Numerical Pain Scale	intensity of pain	The level of pain at 12 weeks
Primary	Score in Numerical Pain Scale	intensity of pain	The level of pain at 6 months
Primary	measure range of motion	range of motion	The range of motion at range of motion at 12 weeks .
Primary	measure range of motion	range of motion	The range of motion at 6 months.
Secondary	measure Functionality	Mandibular Functional Limitation Questionnaire	The functionality at 12 weeks .
Secondary	measure Functionality	Mandibular Functional Limitation Questionnaire	The functionality at 6 months.
Secondary	Biopsychosocial analysis.	Axis II of the diagnostic criterion for temporomandibular disorders	The biopsychosocial analysis at 12 weeks .
Secondary	Biopsychosocial analysis.	Axis II of the diagnostic criterion for temporomandibular disorders	The biopsychosocial analysis at 6 months.