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Clinical Trials/NCT03837587
NCT03837587CompletedNot Applicable

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

Gazi University1 site in 1 country221 target enrollmentStarted: October 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
221
Locations
1
Primary Endpoint
Jaw Functional Limitation Scale-20

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Having a temporomandibular disorder
  • Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification

Exclusion Criteria

  • Pregnant,
  • Neurologic disorder,
  • Infection,
  • Trigeminal or postherpatic neuralgia

Outcomes

Primary Outcomes

Jaw Functional Limitation Scale-20

Time Frame: 10 minutes

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.

Craniofacial Pain and Disability Inventory

Time Frame: 10 minutes

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.

Jaw Functional Limitation Scale-8

Time Frame: 5 minutes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Halime ARIKAN

Research Assistant

Gazi University

Study Sites (1)

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