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Completed

NCT Number: NCT04369092

Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia

Multiple Sclerosis is a chronic inflammatory autoimmune neurological disease characterized by the destruction of myelin in the central nervous system, grey matter and axonal loss. The prevalence of neurogenic dysphagia in this group of patients is estimated to be more than 30%. The aim of this study was investigating of Masseter, Orbicularis Oris, Sternocleidomastoid muscles' viscoelastic properties in MS patients with and without swallowing problems.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Deglutition Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Immune System Diseases Muscle Tonus Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Swallowing Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

About this study

The aim of this study was investigating of Masseter, Orbicularis Oris, Sternocleidomastoid muscles' viscoelastic properties in MS patients with and without swallowing problems. It carried out that myotonometric assessment of muscles in multiple sclerosis patients with dysphagia and comparison of these properties.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being diagnosed with Mc Donald's Multiple sclerosis (MS) in accordance with 2010 criteria,
  • being between the ages of 18-45.

Exclusion criteria

  • having psychological, orthopedic and other neurological disorders,
  • pregnancy,
  • having had an attack in the last 3 months,
  • application of botulinum toxin in the last 6 months.

Treatment and study plan

DYMUS

Other

DYsphagia in MUltiple Sclerosis (DYMUS) that was questionnare and Eating Assessment Tool (EAT-10) were used for assess swallowing problem. All individuals were classified according to DYMUS. The DYMUS Score was 1 or 2 was taken as mild swallowing problems, 3 or more was taken as severe swallowing problems. Patients were divided into three groups; first group that include patients without swallowing problems, second group that include patients with mild swallowing problems, third group that include severe swallowing problems.

Other names: evaluating oropharyngeal dysphagia

Primary outcomes

  1. Myotonometric Measurement

    Time frame: through study completion, average one hour

    MyotonPro® device was used to measure muscles' viscoelastic parameters. The device is valid and reliable for measuring viscoelastic parameters (5, 6). Tonus, stiffness, elasticity of the muscles were recorded. Three measurements were bilaterally taken for each muscle. For each muscle, the average values of stiffness, tone and elasticity were retained as the main MyotonPRO outcomes. Myotonometric measurements were carried out for Masseter, Orbicularis Oris and Sternocleidomastoid (SKM) in supine position.

Secondary outcomes

  1. Eating Assessment Tool

    Time frame: through study completion, average one hour

    Eating Assessment Tool was used to assess symptom of dysphagia. EAT-10 consisted of ten items, each of items was scored from 0 to 4. As the score increases, the patient's symptoms become deterioration.

Sponsors and collaborators

Lead sponsor

Tuba Maden

Other

Registry information

Official study title

Myotonometric Assessment of Muscles in Multiple Sclerosis Patients With Dysphagia

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 30, 2020
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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