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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03837587
Recruitment Status : Active, not recruiting
First Posted : February 12, 2019
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Halime ARIKAN, Gazi University

Study Description
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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.

Condition or disease
Temporomandibular Joint Disorders

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
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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reliability, Validity of The Turkish Version of Craniofacial Pain and Disability Inventory
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

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Groups and Cohorts
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Group/Cohort
Patients group
Patients with temporomandibular disorders


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with temporomandibular disorders between the ages of 18-50
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837587


Locations
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Turkey
Gazi University
Ankara, Turkey, 06500
Sponsors and Collaborators
Gazi University
Investigators
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Study Chair: Seyit ÇITAKER, Prof. Dr. Gazi University
More Information
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Responsible Party: Halime ARIKAN, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03837587    
Other Study ID Numbers: 77082166-604.01.02-
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Halime ARIKAN, Gazi University:
Validity
Reliability
Temporomandibular Joint Disorders
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Facial Pain
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
 Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Pain
Neurologic Manifestations