---
title: Cross Cultural Adaptation, Reliability &Validity of The Arabic Version of 8_Item Jaw Functional Limitation Scale In Temporomandibular Joint Disorders
nct_id: NCT07449221
overall_status: NOT_YET_RECRUITING
sponsor: Cairo University
study_type: OBSERVATIONAL
primary_condition: Temporomandibular Joint Disorders
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07449221.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07449221"
ct_last_update_post_date: 2026-03-04
last_seen_at: "2026-05-12T07:26:59.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Cross Cultural Adaptation, Reliability &Validity of The Arabic Version of 8_Item Jaw Functional Limitation Scale In Temporomandibular Joint Disorders

**NCT ID:** [NCT07449221](https://clinicaltrials.gov/study/NCT07449221)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Cairo University
- **Conditions:** Temporomandibular Joint Disorders
- **Start Date:** 2026-03-07
- **Completion Date:** 2026-05-15
- **CT.gov Last Update:** 2026-03-04

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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
```

## Interventions

- **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.

## Primary Outcomes

- **Face Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)** _(time frame: 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)** _(time frame: 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)** _(time frame: 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)** _(time frame: 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)** _(time frame: 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.

## Secondary Outcomes

- **Visual Analogue Scale (VAS)** _(time frame: 30 minutes)_
- **Fonseca Anamnestic Index (FAI)** _(time frame: 30 minutes)_

## Locations (1)

- El-Kasr Elainy jaw and dental clinics, Giza, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.el-kasr elainy jaw and dental clinics|giza||egypt` — added _(2026-05-12)_

---

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