The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD): Cross-Cultural Adaptation and Psychometric Properties.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 250
- Primary Endpoint
- TSK-TMD-ITA score
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
TSK-TMD-ITA score
Time Frame: 40 minutes
Evaluation of factor structure, scores and identification of cut-offs (\<23; \>31) for research purposes only
Secondary Outcomes
No secondary outcomes reported
Investigators
Alessandro Aquino
Data Manager
University of Milan