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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCairo University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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).

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire Administration

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

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.

Time frame
30 minutes
2

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

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.

Time frame
30 minutes
3

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

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

Time frame
30 minutes
4

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

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

Time frame
30 minutes

Secondary outcomes

1

Visual Analogue Scale (VAS)

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

Time frame
30 minutes
2

Fonseca Anamnestic Index (FAI)

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.

Time frame
30 minutes

Other outcomes

Sponsors and contacts

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