Tampa Scale for Kinesiophobia in Pelvic Pain (TSK-PP). Adaptation, Translation, and Psychometric Validation.

NCT ID: NCT07323849

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to adapt, translate, and evaluate the psychometric properties of the Tampa Scale for Kinesiophobia specifically for patients with pelvic pain (TSK-PP). The main questions it aims to answer are:

Can the TSK-PP reliably and validly measure fear of movement in individuals with pelvic pain?

Participants will complete standardized, self-administered questionnaires at a single point in time that assess:

Demographic and clinical characteristics (age, sex, marital status, medical diagnosis, duration and severity of pelvic pain) Fear of movement using the translated and adapted TSK-PP Fear-avoidance beliefs using the Fear-Avoidance Beliefs Questionnaire (FABQ) Pain catastrophizing using the Pain Catastrophizing Scale (PCS)

No interventions or treatments will be given as part of this study. The results will provide evidence on the reliability, validity, and clinical utility of the TSK-PP for use in research and practice with patients experiencing pelvic pain.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pelvic pain is a complex condition that can significantly impact daily functioning and quality of life. Fear of movement, or kinesiophobia, is recognized as a key psychological factor that may contribute to the transition from acute to chronic pain by promoting avoidance behaviors and limiting physical activity. Accurate measurement of kinesiophobia in patients with pelvic pain is essential for both clinical assessment and research purposes.

The Tampa Scale for Kinesiophobia (TSK) is a widely used instrument for assessing fear of movement, but its original items focus on general or musculoskeletal pain and do not capture the specific concerns of patients with pelvic pain. To address this gap, this study aims to adapt and translate the TSK for application in this population (TSK-PP) and evaluate its psychometric properties.

The study involves a rigorous process of cultural adaptation and translation, including item modification to reflect pelvic pain-specific contexts, forward translation into Spanish, independent review by an external expert, and back-translation into English to ensure conceptual equivalence. Following translation, the TSK-PP will be administered to adult patients with pelvic pain, alongside measures used for construct validation, including the Fear-Avoidance Beliefs Questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS).

Data collected will include demographic and clinical characteristics such as age, sex, marital status, medical diagnosis, duration and severity of pelvic pain. These variables will allow for sample characterization and exploration of relationships with TSK-PP scores during psychometric evaluation.

This study will provide evidence on the reliability, validity, and applicability of the TSK-PP for assessing kinesiophobia in individuals with pelvic pain, supporting its use in both clinical practice and research settings.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pelvic Pain

Adults aged 18 years or older with chronic pelvic pain who are able to read and understand Spanish and have provided informed consent. This cohort will complete self-administered questionnaires to assess fear of movement (TSK-PP) and related psychometric measures.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 years or older.
* Presence of chronic pelvic pain.
* Ability to read and understand Spanish.
* Signed informed consent provided prior to participation.

Exclusion Criteria

* Inability to read or understand Spanish.
* Refusal or failure to provide informed consent for participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Borja Pérez-Domínguez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Physiotherapy. University of Valencia

Valencia, Valencia, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Borja Perez-Dominguez, PhD.

Role: CONTACT

+34 697464680

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Borja Perez-Dominguez, PhD.

Role: primary

+34 697464680

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-FIS-4201075

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Two Point Discrimination
NCT03686748 ACTIVE_NOT_RECRUITING EARLY_PHASE1
Pain Sensitivity During Puberty
NCT05145595 COMPLETED NA