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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04644263
Other study ID # Eylem Kucuk, OkanU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2016
Est. completion date August 2, 2017

Study information

Verified date November 2020
Source Okan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Objective: The aim of this study is to evaluate the validity and reliability of the Turkish version of the 'The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)' questionnaire used to assess kinesiophobia in temporomandibular joint disorders. Method: The "Tampa Kinesiophobia Scale in Temporomandibular Disorders" (TSK-TMD), which consists of 12 item, was adapted to Turkish with the translation and back-translation method. 111 patients (75 females, 36 males) who had been diagnosed with temporomandibular joint for at least 6 months and diagnosed as Temporomandibular Joint Disorder were participated to fill out the questionnaire. In the present study, participants were assessed with the Temporomandibular joint disorders evaluation form, Turkish TSK-TMD-12 item, Visuel Analogue Scale (VAS) and Pain Catastrophizing Scale (PCS). The internal consistency and test-retest reliability with a 3-5 days time were used to evaluate the reliability of the TSK-TMD. The reliability of the corelatıon was checked with PCS. Construct validity was assessed based on confirmatory factor analysis (CFA).


Description:

We used Turkish TSK-TMD-12 item, Visuel Analogue Scale (VAS) and Pain Catastrophizing Scale (PCS) questionnaires in our study.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date August 2, 2017
Est. primary completion date August 2, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:: - volunteer participation in the study, between 18 and 65 years old, - having symptoms for at least 6 months, - being literate, and having communication to understand and answer questions. Exclusion Criteria: - toothache - Cognitive impairment affecting their ability to understand and complete the study questionnaire

Study Design


Related Conditions & MeSH terms

  • Joint Diseases
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Okan University

Outcome

Type Measure Description Time frame Safety issue
Primary The Tampa Scale for Kinesiophobia for Temporomandibular Disorders The original TSK-TMD is an English scale and consists of 18 items to evaluate the fear of movement in TMD patients. 4-point Likert type scoring is used (1-strongly disagree, 2-partially disagree, 3-partially agree and 4- strongly agree). Total score is calculated by reversing 4, 8, 12, 16 items. In this short form, by collecting all points, scores between 12-48 are obtained. The higher the person's score indicates, the higher the kinesiophobia. They suggested that the 12-item version had good reliability and validity as a result of the structural reliability assessment and was more suitable for evaluation in TMD patients. The measurement is one-time and take 20 minutes. It take an average of 6 month after the data of all participants are collected.
Primary Pain Catastrophizing Scala It is a scale developed to detect catastrophic thoughts or feelings and ineffective coping methods of pain experienced by patients in the past. It describes the different thoughts and feelings that individuals can experience while suffering. PCS is a scale consisting of thirteen items and three factors such as helplessness, enlargement and self-reflection. Likert type scoring is evaluated between 0-4 points. The total score ranges from 0-52. The measurement is one-time and take 15 minutes. It take an average of 6 month after the data of all participants are collected.
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