NCT04644263

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

November 18, 2020

Last Update Submit

November 24, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (1)

Validity and reliability

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pre-test: 10 patients temporomandibular disorders evaluated. Inclusion and exlusion criteria listed above. Validation and reliability: 111 patients with temporomandibular disorders evaluated.Inclusion and exlusion criteria listed above.

You may qualify if:

  • 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.

You may not qualify if:

  • toothache
  • Cognitive impairment affecting their ability to understand and complete the study questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physiotherapy

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 25, 2020

Study Start

November 1, 2016

Primary Completion

August 2, 2017

Study Completion

August 2, 2017

Last Updated

November 25, 2020

Record last verified: 2020-11