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Cross Cultural Adaptation, Reliability &Validity of The Arabic Version of 8_Item Jaw Functional Limitation Scale In Temporomandibular Joint Disorders

Temporomandibular Joint Disorders

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
18 años - 65 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
100 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The purpose of this study is to test if the translated Arabic version of the (jaw functional limitation scale -8) JFLS\_8 , valid (face, content, feasibility) ,reliable (internal consistency, test retest) and culturally adapted enough to quantify the impact of temporomandibular joint (TMJ) disorders on jow function in arabic people or not?

Leer la descripción completa

Temporomandibular disorders (TMD) are relatively prevalent among adults, representing a considerable health concern. These disorders negatively affect psychological well-being and overall quality of life, highlighting the importance of accurate assessment and appropriate management strategies. Consequently, there is a growing need for reliable and efficient tools to assess functional limitations associated with TMD.

The Jaw Functional Limitation Scale with 8 items (JFLS-8) is a concise, valid, and reliable instrument used for the assessment of functional limitations related to the masticatory system. It was developed as a shorter version of the JFLS-20 and has been shown to be more practical for use in busy clinical settings while maintaining strong psychometric properties. The JFLS-8 has demonstrated excellent validity and reliability and has been successfully translated and culturally adapted into several languages, confirming its effectiveness as a clinical assessment tool.

Therefore, there is a clear need to translate the JFLS-8 into an Arabic version, perform cultural adaptation, and evaluate its validity and reliability among patients with temporomandibular disorders in Arabic-speaking populations.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

  • Patients aged 18 to 65 years .
  • Diagnosis of temporomandibular disorders ) jaw pain-popping sounds in the jaw -limited jaw movements - orofacial pain ) for one month at least, not receiving actual treatment for the orofacial region (splinting)
  • Being conscious and oriented.
  • Able to read and write in Arabic.
  • Both Genders were included.

Exclusion Criteria:

  • History of trauma (recent head or neck or TMJ severe trauma)
  • Recent surgery at the neck, head or TMJ
  • Diagnosed systemic and psychiatric diseases; diseases that may affect the TMJ, such as ankylosing spondylitis or rheumatoid arthritis; and pregnancy

Población del estudio

Adult male and female patients diagnosed with temporomandibular disorders (TMD), aged 18 to 65 years, who are native Arabic speakers. Participants are recruited from El-Kasr Elainy jaw and dental clinics to evaluate the validity, reliability, feasibility, and cultural adaptation of the Arabic version of the 8-item Jaw Functional Limitation Scale (JFLS-8).

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
Questionnaire Administration OTHER

Participants complete the Arabic version of the 8-item Jaw Functional Limitation Scale (JFLS-8), along with reference measures (Visual Analogue Scale and Fonseca Anamnestic Index), to evaluate validity, reliability, feasibility, and cultural adaptation of the questionnaire.

A subset of participants completes the JFLS-8 again after 2 days to assess test-retest reliability.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Face Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

Plazo: 30 minutes

It will be assessed using the Clarity Index and Expert Proportion of Clearance, judged by two expert panels (5 experts each) to evaluate whether the scale appears clear and relevant.

Content Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

Plazo: 30 minutes

It will be assessed using the Content Validity Index (CVI) and Expert Proportion of Relevance, to confirm that the 8 items adequately cover the construct of jaw functional limitation.

Feasibility of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

Plazo: 30 minutes

It will be evaluated by two factors: time needed to complete the questionnaire and the missed item index (ratio of unanswered items).

Internal Consistency Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

Plazo: 30 minutes

It will be measured using Cronbach's alpha to confirm that all 8 items are measuring the same underlying construct.

Test-Retest Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

Plazo: 2 days

It will be assessed using Spearman's rank correlation coefficient, with a subset of patients completing the JFLS-8 again after 2 days under the same conditions.

Medidas secundarias

Visual Analogue Scale (VAS)

Plazo: 30 minutes

a 10 cm pain intensity scale measuring jaw pain during activity (recorded in cm), used to assess convergent validity with the JFLS-8.

Fonseca Anamnestic Index (FAI)

Plazo: 30 minutes

a 10-item questionnaire classifying TMD severity (scores: 0-15 = no TMD; 20-40 = mild; 45-65 = moderate; 70-100 = severe), also used for convergent/construct validity testing.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

El-Kasr Elainy jaw and dental clinicsGiza, EgyptEstado desconocido

Equipo y fechas

Patrocinador principal
Cairo University
Inicio del estudio
7 mar 2026 Real
Finalización primaria
7 may 2026 Real
Finalización del estudio
15 may 2026 Real
Primera publicación
4 mar 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Cross Cultural Adaptation, Reliability &Validity of The Arabic Version of 8_Item Jaw Functional Limitation Scale In Temporomandibular Joint Disorders

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026