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Набор скоро начнётся NCT06562556

Impact of Breather Device on Ventilatory Effort in Patient With MTMD

Без фазы С лечением TMD

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: the breather device, conventional exercise program.
Кому может быть актуально
Состояния в реестре: TMD. Базовые параметры: 20 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Impact of Breather Device on Ventilatory Effort in Patient With Myogenic Temporomandibular Joint Disorders

Обзор

PURPOSE: The purpose of the study is to investigate the effect of the breather device on ventilatory effort and in patients with myogenic temporomandibular joint disorders To investigate the effect of the breather device on craniocervical angle and oral Health quality in patients with myogenic temporomandibular joint disorders BACKGROUND: TMDs affect between 5% and 12% of the population which is presented by symptoms such as pain in the masticatory muscles with a decrease in the mandible's movement. Other symptoms include ear pain, headache, joint sounds with mandible movement, and/or functional limitations in the jaw like swallowing difficulties commonly found. (Hatice ., et al 2023) Increased prevalence of TMDs has been linked to physical, psychological, and hormonal changes throughout pubertal development. The age predisposes to the development of masticatory system problems in students since symptoms peak between the ages of 20 and 40 years. Women of breeding age are the majority of TMD sufferers. The prevalence of TMD increases globally throughout adolescence and may vary from 7% to 30% of the population (Loster ., et al2017). Alterations of body posture, upper thoracic breathing pattern, and mouth breathing constitute causal factors for the overuse of the accessory inspiratory musculature, which generates hyperactivity and consequently, alteration of head position, and mandibular traction. (Kim., et al 2017) HYPOTHESES: There will be no significant effect of the breather device on ventilatory effort in patients with myogenic temporomandibular joint disorders. There will be no significant effect of the breather device on a craniocervical angle and oral Health quality in patients with myogenic temporomandibular joint disorders RESEARCH QUESTION: Does the breather device can improve ventilatory effort in patients with myogenic temporomandibular joint disorders?.

Подробное описание

Randomized controlled trial which will be conducted on sixty female patients with chronic pain myogenous TMD for more than three months will be included in our study., their ages will range from 20 to 30 years. They will be selected from students of Misr University for Science and Technology to be enrolled in this study. They will participate in this study for 4 weeks The patients will participate and randomly be assigned into two equal groups. Group A: (Experimental group) Thirty patients, will receive a combined treatment program containing respiratory muscle training by the breather device with a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week).

Group B: (Control group) Thirty patients, who will receive a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week)

Вмешательства

  • Устройство the breather device
    investigate the effect of the breather device on ventilatory effort and in patients with myogenic temporomandibular joint disorders
  • Другое conventional exercise program
    -Therapeutic Ultrasound (US): Ultrasound therapy will be applied at the site of pain over the TMJ area with Frequency: 1 MHz, Mode: continuous, Duration: 6 min. each session 2-Myofascial release for masticatory muscles 3-The self-exercise Self exercise: include simplified myo-functional therapy. 10 repetitions, three: five times per day 4-Techniques to correct deglutition: swallowing a small amount of water and speaking while holding a semi-hard small object between the dental arches 5-Relaxatio

Первичные конечные точки

  • spirometer [Срок оценки: 4 weeks]
  • Surface electromyography (sEMG): [Срок оценки: 4 weeks]
Вторичные конечные точки (5)
  • Fonseca Anamnestic Index (FAI) [Срок оценки: 4 weeks]
  • Numeric Pain Rating Scale (NPRS) [Срок оценки: 4 weeks]
  • craniocervical angle measuring [Срок оценки: 4 weeks]
  • The Oral Health Impact Profile Questionnaire OHIP-14 [Срок оценки: 4 weeks]
  • Tape Measurement tool and height scale [Срок оценки: preassessment]

Критерии участия

Критерии включения

  • Inclusion criteria:
  • Sixty female patients who fulfilled the RDC/TMD criteria of myofascial pain and the presence of parafunctional habits, such as bruxism, teeth grinding, mouth breathing, and lip biting.
  • The Patient's ages will range from 20 to 40 years.

4- Patients with a waist-height ratio measuring less than 0.5. 5- Patients with a craniocervical angle measuring from 30 to 50° (Bo-Been et al., 2016).

6- the patients have points from 20-65 on the Fonseca Anamnestic Index (FAI) 7- the patients have the willingness to participate in this study. 8- All patients will sign a consent form before starting the study.

Критерии исключения

Patients will meet one of the following criteria will be excluded from the study:

  • patients undergo surgery or trauma in the orofacial region; systemic or degenerative odontologic disease.
  • The patient has Surgery or trauma in the spine and upper limb.
  • Patients suffering from rheumatic diseases and other severe comorbidities.
  • Patients suffering from any respiratory diseases (restrictive, obstructive, suppurative diseases).
  • Patients suffering from neurological disorders affecting respiratory muscles or any muscular dystrophies

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Walczynska-Dragon K, Baron S, Nitecka-Buchta A, Tkacz E. Correlation between TMD and cervical spine pain and mobility: is the whole body balance TMJ related? Biomed Res Int. 2014;2014:582414. doi: 10.1155/2014/582414. Epub 2014 Jun 19. PMID 25050363

Идентификаторы

NCT: NCT06562556 · breather device for MTMD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗