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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07449221
Enrollment
100
Registered
2026-03-04
Start date
2026-03-07
Completion date
2026-05-15
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

Brief summary

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?

Detailed description

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.

Interventions

OTHERQuestionnaire Administration

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Face Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)30 minutesIt 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)30 minutesIt 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)30 minutesIt 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)30 minutesIt 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)2 daysIt 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.

Secondary

MeasureTime frameDescription
Visual Analogue Scale (VAS)30 minutesa 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)30 minutesa 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.

Countries

Egypt

Contacts

CONTACTWafaa Hashem Ahmed Hasan, B.Sc
wafaahashem859@gmail.com+20 10 50861450
CONTACTDina Sayed Abd Allah, PhD
STUDY_CHAIRSalwa Fadl Abdel Mageed, PhD

Professor, Cairo University

STUDY_DIRECTORDina Sayed Abd Allah, PhD

Lecturer, Cairo University

STUDY_DIRECTOREman Sayed Ahmed Shalaby, PhD

Lecturer, Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026