The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)

The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD): Cross-Cultural Adaptation and Psychometric Properties.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07750509

Acronym

TSK-TMD-ITA

Enrollment

250

Registered

2026-08-06

Start date

2026-09-10

Completion date

2027-01-30

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kinesiophobia, Temporomandibular Disorders (TMDs)

Keywords

TSK-TMD, Kinesiophobia, Temporomandibular Joint Disorders, Cross-Cultural Adaptation, Psychometric Validation, Fear of Movement, Orofacial Pain

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
TSK-TMD-ITA score	40 minutes	Evaluation of factor structure, scores and identification of cut-offs (\<23; \>31) for research purposes only

Outcome results