Reliability, Validity of The Turkish Version of Craniofacial Pain and Disability Inventory

Temporomandibular Joint Disorders Clinical Trial

Official title:

Reliability, Validity of The Turkish Version of Craniofacial Pain and Disability Inventory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837587
• Other study ID #: 77082166-604.01.02-
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2022
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study, we are aim to make the Turkish version validity and reliability of the Cranifacial Pain and Disability Inventory, Jaw Functional Limitation Scale-20, and Jaw Functional Limitation Scale-8.

Description:

Approximately 60% of individuals with temporomandibular disorders (TMD) reported increased pain intensity from midlevel to severe. This was seen at the end of the intervention or work related activities in the quarter of individuals. Therefore, the correct diagnosis of TMD is very important to reduce the economic cost. Craniofacial Pain and Disability Inventory (CF-PDI) is designed based on a biopsychosocial approach. Evidence has shown that CF-PDI is an well-structured, internal consistency, repeatable and valid, and that an objective outcome for the evaluation of pain and discomfort in patients with craniofacial pain. There is no Turkish version and validity study of CF-PDI. Each item is scored between 0-3. The total score ranged from 0 to 63, and a high score indicate a high level of discomfort. The aim of this study was to evaluate the validity and reliability of the Turkish version of CF-PDI. The study of validity and reliability is planned with 105 individuals with TMD. The sociodemographic characteristics of the individuals will be questioned by the investigators and then the patients will be evaluated with CF-PDI, Neck Disability Index (NDI), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Headache Impact Test-6 (HIT-6), Jaw Functional Limitation Scale (JFLS) (Turkish version) and Visual Analogue Scale (VAS). The test-retest will be re-administered by face-to-face interview technique after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: February 1, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Having a temporomandibular disorder

• Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification

Exclusion Criteria:

• Pregnant,

• Canser,

• Trauma,

• Neurologic disorder,

• Infection,

• Trigeminal or postherpatic neuralgia

Related Conditions & MeSH terms

• Facial Pain
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craniofacial Pain and Disability Inventory	Craniofacial Pain and Disability Inventory is a questionnaire that development to individuals with temporomandibular disorders. Each item is scored between 0-3. The total score range from 0 to 63, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.	10 minutes
Primary	Jaw Functional Limitation Scale-20	Jaw Functional Limitation Scale-20 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. Each item is scored between 0-10. It mean that "0= no limitation" and "10= severe limitation".The total score range from 0 to 200, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.	10 minutes
Primary	Jaw Functional Limitation Scale-8	Jaw Functional Limitation Scale-8 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. It is short form of Jaw Functional Limitation Scale-20. Each item is scored between 0-10. It mean that "0= no limitation" and "10= severe limitation".The total score range from 0 to 80, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.	5 minutes