NCT07750509

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Sep 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2027

23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 2, 2026

Last Update Submit

August 2, 2026

Conditions

Temporomandibular Disorders (TMDs)Kinesiophobia

Keywords

TSK-TMDKinesiophobiaTemporomandibular Joint DisordersCross-Cultural AdaptationPsychometric ValidationFear of MovementOrofacial Pain

Outcome Measures

Primary Outcomes (1)

  • TSK-TMD-ITA score

    Evaluation of factor structure, scores and identification of cut-offs (\<23; \>31) for research purposes only

    40 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending the Temporomandibular Disorders Clinic, Maxillofacial Surgery Unit, San Paolo Hospital, Milan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint DisordersKinesiophobiaFacial Pain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPhobic DisordersAnxiety DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Data Manager

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 6, 2026

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

January 7, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

August 6, 2026

Record last verified: 2026-08