NCT05712655

Brief Summary

The aim of this study was to evaluate masticatory muscle electrical activity in post-pubertal females with forward head posture (FHP) and temporomandibular disorders (TMD) as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

January 22, 2023

Last Update Submit

February 4, 2023

Conditions

Head PainTMJ Disorder

Keywords

Forward head postureTemporomandibular disordersMasticatory musclesElectromyographypost-pubertal females

Outcome Measures

Primary Outcomes (1)

  • Electromyographic (EMG) activity of masticatory muscles

    Measurement of bilateral EMG activity of Masseter and Anterior Temporalis muscles

    8 months

Secondary Outcomes (2)

  • Measurement of cranivertebral angle (CVA)

    8 months

  • Assessment of research Diagnostic criteria for temporomandibular Disorders (RDC/TMDS)

    8 months

Study Arms (2)

Study group

Post-pubertal females with forward head posture and temporomandibular disorders

Other: Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles.

Control group

Post-pubertal females with neutral head posture and with no temporomandibular disorders

Other: Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles.

Interventions

Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles.OTHER

Assessment was done by surface electromyography (sEMG) device.

Control groupStudy group

Eligibility Criteria

Age17 Years - 22 Years
Sexfemale(Gender-based eligibility)
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

They were invited to participate in the study through flyers and social media invitations

You may qualify if:

  • Age ranging from 17 to 22 years.
  • Body mass index ranging from 18 to 25 kg/m2.
  • Having a normal menstrual cycle.
  • Spending four to six hours per day with bad posture on computer, laptop or smart phones.
  • Fully dentate subjects.

You may not qualify if:

  • Having dental loss, acquired dental anomalies, current use of dental prostheses, malocclusion, sleep bruxism.
  • Having inflammatory diseases of the face or jaw, fibromyalgia, or any fractures or surgeries in the orofacial or neck areas.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nasser Institute for research and treatment

Cairo, Egypt

Location

MeSH Terms

Conditions

HeadacheTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Amel M Yousef, Professor

    Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 3, 2023

Study Start

July 1, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

EG(1)