The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Temporomandibular Disorders (TMDs), Kinesiophobia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD): Cross-Cultural Adaptation and Psychometric Properties.
Overview
This observational, cross-sectional study aims to translate, culturally adapt, and psychometrically validate the Italian version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD-ITA). Patients referred to the TMD outpatient clinic of the Department of Maxillofacial Surgery, San Paolo Hospital (Milan, Italy), will complete the translated questionnaire along with measures of pain, disability, catastrophizing, anxiety/depression, stress, and central sensitization. The study will assess the factor structure, internal consistency, test-retest reliability, and convergent/discriminant validity of the TSK-TMD-ITA in the Italian TMD population.
Detailed description
Temporomandibular Disorders (TMD) are common musculoskeletal conditions in which kinesiophobia acts as a psychosocial mediator of pain chronification and disability. No validated Italian version of the TSK-TMD currently exists. This study follows Beaton et al.'s five-phase cross-cultural adaptation methodology (forward translation, synthesis, back-translation, expert panel review, and cognitive debriefing) followed by psychometric evaluation in accordance with COSMIN guidelines. Approximately 250 participants will be recruited via consecutive convenience sampling across three sub-samples: exploratory factor analysis (60-120 subjects), confirmatory factor analysis (\~200 subjects), and test-retest reliability (30-50 stable subjects). Data will be collected via paper-based self-administered questionnaires and recorded pseudonymously in a REDCap database, in compliance with GDPR (EU Regulation 2016/679).
Primary outcome measures
- TSK-TMD-ITA score [Time frame: 40 minutes]
Eligibility criteria
Inclusion Criteria: - Age ≥18 years - diagnosis of TMD according to DC/TMD criteria by a gnathologist/maxillofacial surgeon - native Italian speaker or good command of the language - ability to provide written informed consent.
Exclusion Criteria: Severe neurological/psychiatric disorders or cognitive impairment; ongoing dental/therapeutic treatments that rapidly alter clinical status; inability to comprehend items; use of medications that alter neuromuscular function for conditions other than TMD; pregnancy; substance or alcohol abuse; craniocervicofacial neoplasms
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07750509 · TSK-TMD-ITA · CET 182-2026