Clinical trial NCT04884152: Telerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism
Official title: Investigation of the Effectiveness of Telerehabilitation in Individuals Myofascial Temporomandibular Dysfunction With Bruxism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain
Temporomandibular Disorder
Bruxism
Keywords: Myofascial Pain
Temporomandibular Disorder
Bruxism
Telerehabilitation
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effects of Home Exercise Therapy (HET) and Telerehabilitation in patients with myofascial temporomandibular disorders (TMD)with bruxism.

Detailed description: Home Exercise will be Group 1 and Telerehabilitation group will be Group 2.

Group 1 HET, will include an educational training program about parafunctional activities of TMD disorders and bruxism and active exercises for 4 weeks.

As part of the Home exercise program, a written document will be prepared, including relaxation, breathing training, posture, stretching, and strengthening exercises to be given to the patients.

Group 2, in addition to the training and written document, the second group will receive the same exercises using telerehabilitation once a week by video call, and reminder messages will be sent to the patients 3 times a week.

Eligibility criteria: Inclusion Criteria:

* Ages between 18 and 65 years old
* Patients with TMD in the myofascial Group Ia, Ib according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and diagnosed with bruxism
* Having pain ≥ 3 according to the Visual Analog Scale
* Those who have not received medical treatment for the last 3 months and will not receive it during the treatment process will be included in the study.

Exclusion Criteria:

* Ages under 18 and over 65 years old
* Patients with disc displacement and/or TMJ degeneration
* Patients who have orthodontic or splint treatment
* Patients with musculoskeletal problems in which systemic specific pathological conditions such as cervical and/or temporomandibular joint (TMJ) problem malignancy, fracture, the rheumatoid disease is proven
* Patients who have undergone any surgery related to the cervical and/or TMJ
* Patients with facial paralysis
* Patients who regularly use analgesic or anti-inflammatory drugs
* Patients who have received physical therapy associated with TMJ in less than 3 months
* Patients with a history of trauma (whiplash injury, condylar trauma, fracture)
* Patients with cognitive deficits
* Participation rate lower than 80% of the program schedule

Primary outcomes:
measure: Change from Baseline in Pain at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from Baseline in Mandibular range of movements at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from Baseline in Neck disability at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from Baseline in Headache at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from Baseline in Sleep Quality at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from Baseline in Oral Behavior at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from Baseline in Quality of life at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Change from Baseline in Head and Shoulder Posture at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from Baseline in Anxiety at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from Baseline in Fatigue at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer
role: STUDY_DIRECTOR
References: