Temporomandibular Disorders (TMDs)TSK-TMD-ITANCT07750509
The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)
An observational study of Temporomandibular Disorders (TMDs) and Kinesiophobia, run by Alessandro Aquino.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMDs), Kinesiophobia
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 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
About this study
Official title: The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD): Cross-Cultural Adaptation and Psychometric Properties.
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.
Read the 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).
- Conditions
- Temporomandibular Disorders (TMDs), Kinesiophobia
- Keywords
- TSK-TMD, Kinesiophobia, Temporomandibular Joint Disorders, Cross-Cultural Adaptation, Psychometric Validation, Fear of Movement, Orofacial Pain
- Medical subject headings
- Temporomandibular Joint Disorders, Kinesiophobia, Facial Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
TSK-TMD-ITA score
Evaluation of factor structure, scores and identification of cut-offs (<23; >31) for research purposes only
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start10 Sep 2026 (estimated)
- Primary completion7 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMDs)Studies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alessandro Aquino
- Sponsor type
- University, hospital or other
- Collaborators
- Presidio Ospedale San Paolo. Milano
- Responsible party
- Sponsor-investigator, Alessandro Aquino, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750509
- Sponsor's protocol ID
- TSK-TMD-ITA
- Other IDs
- CET 182-2026
- Acronym
- TSK-TMD-ITA
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 7 Aug 2026
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD): Cross-Cultural Adaptation and Psychometric Properties.
- ClinicalTrials.gov ID
- NCT07750509
- Acronym / sponsor ID
- TSK-TMD-ITA / TSK-TMD-ITA
- Conditions
- Temporomandibular Disorders (TMDs), Kinesiophobia
- Keywords
- TSK-TMD, Kinesiophobia, Temporomandibular Joint Disorders, Cross-Cultural Adaptation, Psychometric Validation, Fear of Movement, Orofacial Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Alessandro AquinoUniversity, hospital or other
- Collaborators
- Presidio Ospedale San Paolo. Milano
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 6 Aug 2026 (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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the Temporomandibular Disorders Clinic, Maxillofacial Surgery Unit, San Paolo Hospital, Milan
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
TSK-TMD-ITA score
Time frame: 40 minutes
Evaluation of factor structure, scores and identification of cut-offs (<23; >31) for research purposes only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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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.
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 Disorders (TMDs) and Kinesiophobia, run by Alessandro Aquino.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 7 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
TSK-TMD-ITA score (time frame: 40 minutes). 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 7 Aug 2026.