Clinical trial NCT06562556: Impact of Breather Device on Ventilatory Effort in Patient With MTMD
Official title: Impact of Breather Device on Ventilatory Effort in Patient With Myogenic Temporomandibular Joint Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: TMD
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

Brief summary: 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?.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:

  1. 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.
  2. 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.

Exclusion Criteria:

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

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

Primary outcomes:
measure: spirometer
timeFrame: 4 weeks
measure: Surface electromyography (sEMG):
timeFrame: 4 weeks
Secondary outcomes:
measure: Fonseca Anamnestic Index (FAI)
timeFrame: 4 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4 weeks
measure: craniocervical angle measuring
timeFrame: 4 weeks
measure: The Oral Health Impact Profile Questionnaire OHIP-14
timeFrame: 4 weeks
measure: Tape Measurement tool and height scale
timeFrame: preassessment
Other outcomes:
Locations:
Study officials:
References:
citation: 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.