Temporomandibular Joint DisordersNCT04644263
Turkish Validity and Reliability of The Tampa Scale for Kinesiophobia for Temporomandibular Disorders
An observational study of Temporomandibular Joint Disorders, run by Okan University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 2 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- toothache
- Cognitive impairment affecting their ability to understand and complete the study questionnaire
About this study
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).
Read the detailed description
We used Turkish TSK-TMD-12 item, Visuel Analogue Scale (VAS) and Pain Catastrophizing Scale (PCS) questionnaires in our study.
- Conditions
- Temporomandibular Joint Disorders
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Validity and reliability | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The measurement is one-time and take 15 minutes. It take an average of 6 month after the data of all participants are collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Nov 2016
- Primary completion2 Aug 2017
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem KÜÇÜK, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644263
- Sponsor's protocol ID
- Eylem Kucuk, OkanU
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of The Tampa Scale for Kinesiophobia for Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04644263
- Acronym / sponsor ID
- Eylem Kucuk, OkanU
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
We used Turkish TSK-TMD-12 item, Visuel Analogue Scale (VAS) and Pain Catastrophizing Scale (PCS) questionnaires in our study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validity and reliability | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- toothache
- Cognitive impairment affecting their ability to understand and complete the study questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Tampa Scale for Kinesiophobia for Temporomandibular Disorders
Time frame: The measurement is one-time and take 20 minutes. It take an average of 6 month after the data of all participants are collected.
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.
Pain Catastrophizing Scala
Time frame: The measurement is one-time and take 15 minutes. It take an average of 6 month after the data of all participants are collected.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders, run by Okan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (time frame: The measurement is one-time and take 20 minutes. It take an average of 6 month after the data of all participants are collected.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.