Clinical trial NCT05006963: Tele-Rehabilitation in Patients With Temporomandibular Dysfunction
Official title: Tele-Rehabilitation in Patients With Temporomandibular Dysfunction: Randomized, Controlled and Blind
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Disorder
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Keywords: temporomandibular joint disorders
clinical protocols
physiotherapy
remote consultation
telemedicine
telehealth
telerehabilitation
teletherapy
telepractice
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Score in Numerical Pain Scale
timeFrame: The level of pain at 12 weeks
measure: Score in Numerical Pain Scale
timeFrame: The level of pain at 6 months
measure: measure range of motion
timeFrame: The range of motion at range of motion at 12 weeks .
measure: measure range of motion
timeFrame: The range of motion at 6 months.
Secondary outcomes:
measure: measure Functionality
timeFrame: The functionality at 12 weeks .
measure: measure Functionality
timeFrame: The functionality at 6 months.
measure: Biopsychosocial analysis.
timeFrame: The biopsychosocial analysis at 12 weeks .
measure: Biopsychosocial analysis.
timeFrame: The biopsychosocial analysis at 6 months.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University Nove de Julho
Study officials:
References: