Efficacy of the Myofunctional Therapy on Oral Dysphagia

NCT04636606 | Completed

• 1 other identifier: 2019/131
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dysphagia, Oral Phase; Temporomandibular Disorders

Keywords

Oral Dysphagia; Temporomandibular Disorders; Quality of Life; Pain

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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).

  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.

  Baseline, 10 weeks, 6 months

• Change from Baseline in Quality of life at 10 weeks and 6 months

  The quality of life will be evaluated with Swallowing-related Quality of Life questionnaire (Swal-QoL). The SWAL-QoL is a dysphagia specific quality of life instrument consisting of 44 items (11 scales) assessing ten QOL domains: food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Sleep and fatigue contribute to general QOL, whereas the other domains are contributors to dysphagia-specific QOL. The total SWAL-QOL score includes 23 items from seven domains.

  Baseline, 10 weeks, 6 months

Study Arms (3)

Home Exercise

ACTIVE COMPARATOR

Home Exercise program includes educational training program about parafunctional activities of patients having oral dysphagia with temporomandibular disorders. Program includes stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises.

Procedure: Home Exercise

Manual Therapy Combined with Home Exercise

ACTIVE COMPARATOR

Manual Therapy includes deep friction massage and myofascial relaxation techniques to masticatory and neck muscles, active and resistant temporomandibular joint movements, temporomandibular joint distraction and mobilization, stretching techniques to the temporomandibular joint, mobilization of upper cervical joints. Home Exercise program includes educational training program about parafunctional activities of patients having oral dysphagia with temporomandibular disorders. Program includes stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises.

Procedure: Manual Therapy Combined with Home Exercise

Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise

ACTIVE COMPARATOR

Orofacial Myofunctional therapy includes stretching the tongue muscles, tongue rotation exercises, isometric and isotonic strengthening of the tongue, special maneuver, effortful swallow exercise, strengthening exercise of hyoidal muscles. Manual Therapy includes deep friction massage and myofascial relaxation techniques to masticatory and neck muscles, active and resistant temporomandibular joint movements, temporomandibular joint distraction and mobilization, stretching techniques to the temporomandibular joint, mobilization of upper cervical joints. Home Exercise program includes educational training program about parafunctional activities of patients having oral dysphagia with temporomandibular disorders. Program includes stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises.

Procedure: Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise

Interventions

Home Exercise PROCEDURE

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

Home Exercise

Manual Therapy Combined with Home Exercise PROCEDURE

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

Manual Therapy Combined with Home Exercise

Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise PROCEDURE

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

Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Umut Rehabilitation Center

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders; Temporomandibular Joint Disorders; Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Aysenur Tuncer, PhD

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, Msc

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 19, 2020
• Study Start: December 1, 2020
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)