An observational study in Temporomandibular Disorders (TMDs) and Kinesiophobia, sponsored by Alessandro Aquino. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Alessandro Aquino · Observational
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.
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).
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's planned enrollment of 250 is above the median of 91 across 165 observational studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →This is the only study on the registry with Alessandro Aquino as lead sponsor.
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Patients attending the Temporomandibular Disorders Clinic, Maxillofacial Surgery Unit, San Paolo Hospital, Milan
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 .
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TSK-TMD-ITA score
Evaluation of factor structure, scores and identification of cut-offs (\<23; \>31) for research purposes only
Time frame: 40 minutes
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders →