Efficacy of the Myofunctional Therapy on Oral Dysphagia

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Home Exercise

Manual Therapy Combined with Home Exercise

Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise

About this trial

This is an interventional treatment trial for Dysphagia, Oral Phase focused on measuring Oral Dysphagia, Temporomandibular Disorders, Quality of Life, Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Umut Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Home Exercise

Manual Therapy Combined with Home Exercise

Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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).

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04636606

First Posted

November 15, 2020

Last Updated

August 23, 2021

Sponsor

Hasan Kalyoncu University

1. Study Identification

Unique Protocol Identification Number

NCT04636606

Brief Title

Efficacy of the Myofunctional Therapy on Oral Dysphagia

Official Title

The Efficacy of the Myofunctional Therapy on Oral Dysphagia in Patients With Temporomandibular Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

June 25, 2021 (Actual)

Study Completion Date

June 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia, Oral Phase, Temporomandibular Disorders

Keywords

Oral Dysphagia, Temporomandibular Disorders, Quality of Life, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Home Exercise

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Manual Therapy Combined with Home Exercise

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Home Exercise

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Manual Therapy Combined with Home Exercise

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline in Pain at 10 weeks and 6 months

Description

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

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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.

Time Frame

Baseline, 10 weeks, 6 months

Title

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

Description

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.

Time Frame

Baseline, 10 weeks, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aysenur Tuncer, PhD

Organizational Affiliation

Hasan Kalyoncu University

Official's Role

Study Director

Facility Information:

Facility Name

Umut Rehabilitation Center

City

Şanlıurfa

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

No

Dysphagia, Oral Phase, Temporomandibular Disorders

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial