Pelvic PainNCT07323849
Tampa Scale for Kinesiophobia in Pelvic Pain (TSK-PP). Adaptation, Translation, and Psychometric Validation.
An observational study of Pelvic Pain, run by University of Valencia at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Pain
- How many people
- 170 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Study participants will be selected from the adult population experiencing chronic pelvic pain. Eligible participants are adults aged 18 years or older who are able to read and understand Spanish and provide informed consent. The population includes individuals with varying demographic and clinical characteristics, such as age, sex, marital status, medical diagnosis, duration of pelvic pain, and pain severity. Participants will complete self-administered questionnaires at a single time point.
Who may be able to join
- Age 18 years or older.
- Presence of chronic pelvic pain.
- Ability to read and understand Spanish.
- Signed informed consent provided prior to participation.
Who cannot join
- Inability to read or understand Spanish.
- Refusal or failure to provide informed consent for participation in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Physiotherapy. University of Valencia
Valencia, Valencia, 46010
About this study
Official title: Tampa Scale for Kinesiophobia for Pelvic Pain (TSK-PP). Adaptation, Translation, and Psychometric Validation.
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?
Read more
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.
Read the detailed description
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
- Pelvic Pain
- Keywords
- Pelvic Pain, Kinesiophobia, Pain Measurement, Questionnaires / Psychometrics, Pain
- Medical subject headings
- Pelvic Pain, Kinesiophobia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
Fear of movement will be assessed using the Tampa Scale for Kinesiophobia adapted for patients with pelvic pain (TSK-PP), a translated and culturally adapted version of the original Tampa Scale for Kinesiophobia. The TSK-PP is a self-reported questionnaire consisting of 17 items, with total scores ranging from 17 to 68. Higher scores indicate greater levels of kinesiophobia (worse outcome).
Measured: Baseline
Secondary outcomes (2)
Fear-Avoidance Beliefs
Fear-avoidance beliefs will be assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ), a self-reported instrument designed to evaluate beliefs about physical activity and work that may contribute to pain-related avoidance behaviors. The FABQ includes two subscales: Physical Activity (FABQ-PA; score range 0-24) and Work (FABQ-W; score range 0-42). Higher scores indicate stronger fear-avoidance beliefs (worse outcome).
Measured: Baseline
Pain Catastrophizing
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a self-reported questionnaire designed to measure catastrophic thinking related to pain, including rumination, magnification, and helplessness. The PCS total score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing (worse outcome).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Dec 2025
- Primary completion15 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borja Pérez-Domínguez, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323849
- Sponsor's protocol ID
- 2025-FIS-4201075
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tampa Scale for Kinesiophobia for Pelvic Pain (TSK-PP). Adaptation, Translation, and Psychometric Validation.
- ClinicalTrials.gov ID
- NCT07323849
- Acronym / sponsor ID
- 2025-FIS-4201075
- Conditions
- Pelvic Pain
- Keywords
- Pelvic Pain, Kinesiophobia, Pain Measurement, Questionnaires / Psychometrics, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 7 Jan 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.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from the adult population experiencing chronic pelvic pain. Eligible participants are adults aged 18 years or older who are able to read and understand Spanish and provide informed consent. The population includes individuals with varying demographic and clinical characteristics, such as age, sex, marital status, medical diagnosis, duration of pelvic pain, and pain severity. Participants will complete self-administered questionnaires at a single time point.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Presence of chronic pelvic pain.
- Ability to read and understand Spanish.
- Signed informed consent provided prior to participation.
Key exclusion criteria (2 listed)
- Inability to read or understand Spanish.
- Refusal or failure to provide informed consent for participation in the study
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
Kinesiophobia
Time frame: Baseline
Fear of movement will be assessed using the Tampa Scale for Kinesiophobia adapted for patients with pelvic pain (TSK-PP), a translated and culturally adapted version of the original Tampa Scale for Kinesiophobia. The TSK-PP is a self-reported questionnaire consisting of 17 items, with total scores ranging from 17 to 68. Higher scores indicate greater levels of kinesiophobia (worse outcome).
2 secondary outcomes
Fear-Avoidance Beliefs
Time frame: Baseline
Pain Catastrophizing
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Pelvic Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Active, not recruiting
Hypopressive-Core Stabilization With and Without Whole-Body Vibration in Postpartum Pelvic Girdle Pain
Postpartum Pelvic Girdle Pain
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Not yet recruiting
Focused Ultrasound Neuromodulation for Chronic Pain
Chronic Pain, Sickle Cell Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Pain, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Kinesiophobia (time frame: Baseline). 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 31 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.