Efficacy of the Myofunctional Therapy on Oral Dysphagia

Hasan Kalyoncu University60 enrolled

Overview

The aim of the study is to analyze the effects of orofacial myofunctional therapy (OMT) on oral dysphagia (OD) in patients with temporomandibular disorders (TMD).

60 subjects with TMD, according to the Research Diagnostic Criteria, will be included in the study after voluntary consent form will be filled out. Subjects will randomly be divided into 3 groups according to the order. Home Exercise (n=20) will be the Group 1, Home Exercise combined with Manual Therapy (n=20) will be the Group 2, and Orofacial Myofunctional Therapy combined with Home Exercise and MT treatment (n=20) will be the Group 3. Group 1 will include educational training program about parafunctional activities of TMD disorders and active exercises for masticatory and neck muscles with 10 repetitions, 3 times a day, and for 10 weeks. Group 2 will receive home exercise training program and manual therapy program which is planned to last 30 minutes; will be applied twice a week, for 10 weeks. Group 3 will include stretching and strengthening of the tongue muscles, tongue rotation exercises, effortful swallowing, strengthen the hyoidal muscles, which is planned to last 40 minutes, will be applied twice a week, for 10 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dysphagia, Oral Phase Temporomandibular Disorders

Interventions

Home ExercisePROCEDURE

Educational training program about oral dysphagia in patients with temporomandibular disorders.

Manual Therapy Combined with Home ExercisePROCEDURE

Manual therapy program combined with educational training program about oral dysphagia in patients with temporomandibular disorders.

Orofacial Myofunctional Therapy combined with Manual Therapy and Home ExercisePROCEDURE

Orofacial Myofunctional Therapy program with combination of Manual therapy and educational training program about oral dysphagia in patients with temporomandibular disorders.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ages between 18 and 65 years old * Patients with diagnosis of Group Ia, Ib, IIa and and III according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) * Having pain ≥ 4 according to the Visual Analog Scale * Having score ≥2 points on the Eating Assessment Tool-10 questionnaire * Patients who had difficulty in water swallowing tests Exclusion Criteria: * Ages under 18 and over 65 years old * Patients with a diagnosis of Group II b,c according to the RDC / TMD evaluation * Diagnosis of psychiatric illness * Patients with musculoskeletal problems in which systemic specific pathological conditions such as cervical and / or temporomandibular joint (TMJ) problem malignancy, fracture, rheumatoid disease is proven * Patients who have undergone any surgery related to the cervical and/or TMJ * Patients with facial paralysis * Patients with swallowing difficulties due to the neurological disorders * Patients who have received physical therapy associated with TMJ in less than 6 months * Patients with cognitive deficits * Participation rate lower than 80% of the program schedule

Locations (1)

Umut Rehabilitation Center

Sanliurfa, Turkey (Türkiye)

Outcomes

Primary Outcomes

Change from Baseline in Pain at 10 weeks and 6 months

Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 10 weeks intervention and at the end 6 months from baseline.

Time frame: Baseline, 10 weeks, 6 months

Change from Baseline in Tongue strength and endurance at 10 weeks and 6 months

Tongue strength will be assessed by Iowa Oral Performance Instrument with the measurement of muscle strength by tongue muscle pressure. Tongue endurance will be measured with the Iowa Oral Performance Instrument by quantifying the length of time that a patient may maintain 50% of his or her maximum pressure.

Time frame: Baseline, 10 weeks, 6 months

Change from Baseline in Jaw Function limitation at 10 weeks and 6 months

Jaw function limitation will be measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients will be asked from 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has 3 subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).

Time frame: Baseline, 10 weeks, 6 months

Change from Baseline in Swallowing dysfunction at 10 weeks and 6 months

The first evaluation for swallowing dysfunction will be assessed with 100 ml water swallow test (WST). For the WST, we will be ask participants to consume 100ml of water in the shortest amount of time. Patients will be assessed to have failed the WST according to published criteria of, (1) coughing or choking post swallow, (2) having a wet voice quality post swallow, or (3) being unable to drink the whole amount of water. Furthermore, the swallowing speed will be evaluated as the amount of consumed water divided by the elapsed time. The second evaluation for swallowing dysfunction will be assessed with Eating Assessment Tool-10 (EAT-10) questionnaire. The EAT-10 is a self-administered, symptom-specific outcome assessment for swallowing dysfunction, demonstrating good consistency, reproducibility, and validity. It consists of 10 questions answered in a scale of 0 to 4 (0: no problem to 4: severe problem), with the higher scores indicating severe dysphagic symptoms.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.