PainNCT07323797
Overlapping Pelvic and Temporomandibular Pain: A Cross-Sectional Analysis of Psychosocial and Sensitization Mechanisms
An observational study of Pain, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this observational study is to learn whether pain in the temporomandibular joint is associated with pelvic pain in adults, and to explore psychosocial and pain sensitization factors that may contribute to both conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 133 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2025to 1 Dec 2025
- 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 general population experiencing chronic pain. The study population includes individuals aged 18 years or older who report pain in the orofacial (temporomandibular) region, the pelvic region, both regions, or chronic pain in other body areas without involvement of the temporomandibular or pelvic regions. Participants must be able to read and understand Spanish and provide informed consent.
Who may be able to join
- Age 18 years or older.
- Presence of chronic pain
- Ability to complete self-administered questionnaires.
- Signed informed consent provided prior to participation.
Who cannot join
- Inability to read or understand Spanish.
- Failure or refusal 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
The goal of this observational study is to learn whether pain in the temporomandibular joint is associated with pelvic pain in adults, and to explore psychosocial and pain sensitization factors that may contribute to both conditions.
The main questions it aims to answer are:
Read more
Is temporomandibular joint dysfunction associated with pelvic pain in the adult population? Are psychosocial factors and indicators of central pain sensitization related to the co-occurrence of these pain conditions?
Participants will complete standardized, self-administered questionnaires at a single point in time that assess:
Temporomandibular joint symptoms Pelvic pain symptoms Psychosocial factors and pain sensitization features
No treatments or interventions will be given as part of this study.
Read the detailed description
Chronic pain is a major public health concern due to its high prevalence and its significant impact on quality of life, daily functioning, and overall well-being. Among chronic pain types, nociplastic pain is characterized by persistent pain in the absence of clear tissue damage and is associated with alterations in central pain processing, including central sensitization and dysfunction of the central nervous system. These alterations may manifest as widespread pain sensitivity, autonomic dysregulation, and changes in sensory integration, contributing to long-lasting and diffuse pain experiences.
Individuals with chronic pain frequently report pain in more than one body region, a phenomenon known as Chronic Overlapping Pain Conditions (COPC). The presence of overlapping pain conditions suggests shared underlying mechanisms, such as central sensitization and common psychosocial modulators, which may explain the co-occurrence of different chronic pain syndromes. In this context, temporomandibular joint (TMJ) pain and pelvic pain are of particular interest, as emerging evidence indicates a possible association between these conditions.
Given the existing evidence linking chronic pain conditions across different body regions, further investigation into the co-occurrence of TMJ dysfunction and pelvic pain is warranted. This observational, cross-sectional study aims to characterize the association between these two pain conditions in an adult population and to explore demographic, socioeconomic, psychosocial, and pain-related factors that may help explain their relationship. By improving understanding of shared pain mechanisms, this research seeks to inform future clinical approaches that are more comprehensive and integrative.
Data will be collected at a single time point using standardized, self-administered questionnaires, in accordance with the STROBE guidelines for observational research. Demographic variables will include age, sex, and-among female participants-reproductive and hormonal history (pregnancy, childbirth, episiotomy, cesarean section, and menopausal status). Additional variables will include marital status, current medication use, height, weight, smoking status, physical activity levels, and the duration of orofacial and/or pelvic pain symptoms. Socioeconomic factors such as educational level, classified according to the International Standard Classification of Education (ISCED), and monthly household income, categorized into national income deciles, will also be recorded.
The co-occurrence of chronic pain conditions will be assessed using the Chronic Overlapping Pain Conditions Screener (COPC-S). Pain intensity will be measured using the Numerical Rating Scale (NRS), while fear of movement related to orofacial pain will be evaluated using the Tampa Scale of Kinesiophobia adapted for temporomandibular disorders (TSK-TMD). The presence of central sensitization symptoms will be assessed with the Central Sensitization Inventory (CSI). Psychosocial influences on pain will be examined through measures of health-related quality of life (Short Form-12), perceived stress (Perceived Stress Scale-10), and anxiety (short form of the State-Trait Anxiety Inventory, STAI-6).
By systematically examining the overlap between temporomandibular and pelvic pain and their associated biopsychosocial factors, this study aims to provide preliminary evidence on shared mechanisms of chronic pain. The findings may support the development of more holistic assessment strategies and integrated clinical interventions for individuals experiencing chronic overlapping pain conditions.
- Conditions
- Pain
- Keywords
- Chronic Pain, Comorbidity, Cross-sectional, Pelvic Pain, Temporomandibular Joint Disorders
- Medical subject headings
- Pain, Chronic Pain, Pelvic Pain, Temporomandibular Joint Disorders
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 |
|---|---|---|
| Chronic Pain | Adults with chronic pain who do not report pain in the pelvic region or the temporomandibular joint. | |
| Temporomandibular Pain Only | Adults with chronic pain who report pain or dysfunction in the temporomandibular joint region but do not report pelvic pain. | |
| Pelvic Pain Only | Adults with chronic pain who report pelvic pain but do not report temporomandibular joint pain. | |
| Overlapping Pelvic and Temporomandibular Pain | Adults with chronic pain who report both pelvic pain and temporomandibular joint pain, consistent with chronic overlapping pain conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-occurrence of Chronic Pain Conditions
The presence and degree of overlapping chronic pain conditions will be assessed using the Chronic Overlapping Pain Conditions Screener (COPC-S). This validated tool identifies co-occurring pain conditions across different body regions and will be used to classify participants into pain groups and to quantify overlap between temporomandibular and pelvic pain.
Measured: Baseline
Secondary outcomes (6)
Pain Intensity
Pain intensity in the temporomandibular and/or pelvic regions will be measured using the Numerical Rating Scale (NRS). Participants will rate their pain intensity on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). The NRS is a widely used and validated measure of pain severity in chronic pain populations.
Measured: Baseline
Kinesiophobia Related to Temporomandibular Pain
Fear of movement related to orofacial pain will be assessed using the Tampa Scale of Kinesiophobia for Temporomandibular Disorders (TSK-TMD), a validated and culturally adapted version of the original Tampa Scale of Kinesiophobia. The TSK-TMD is a self-reported questionnaire that evaluates pain-related fear and avoidance behaviors associated with jaw movement in individuals with temporomandibular disorders. Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia (worse outcome).
Measured: Baseline
Central Sensitization Symptoms
Central sensitization-related symptoms will be assessed using the Central Sensitization Inventory (CSI), Spanish-validated version. The CSI is a self-reported questionnaire designed to evaluate symptoms associated with altered central pain processing, including widespread pain, fatigue, sleep disturbances, and cognitive difficulties. The total score ranges from 0 to 100, with higher scores indicating a greater severity of central sensitization symptoms (worse outcome).
Measured: Baseline
Health-Related Quality of Life
Health-related quality of life will be assessed using the Short Form-12 Health Survey (SF-12), Spanish-validated version. The SF-12 is a self-reported instrument that generates two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), reflecting physical and mental aspects of overall functioning and well-being. Each composite score is standardized to range from 0 to 100, with higher scores indicating better perceived health status (better outcome).
Measured: Baseline
Perceived Stress
Perceived stress levels will be assessed using the Perceived Stress Scale-10 (PSS-10), a self-reported questionnaire that evaluates the degree to which individuals perceive their lives as stressful during the past month. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).
Measured: Baseline
Anxiety Levels
Anxiety will be assessed using the State-Trait Anxiety Inventory, 6-item short form (STAI-6), a self-reported instrument designed to measure current (state) anxiety symptoms and emotional tension. Total scores range from 6 to 24, with higher scores indicating greater anxiety levels (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 start9 Sep 2025
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 133 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
- NCT07323797
- Sponsor's protocol ID
- 2025-FIS-4199837
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overlapping Pelvic and Temporomandibular Pain: A Cross-Sectional Analysis of Psychosocial and Sensitization Mechanisms
- ClinicalTrials.gov ID
- NCT07323797
- Acronym / sponsor ID
- 2025-FIS-4199837
- Conditions
- Pain
- Keywords
- Chronic Pain, Comorbidity, Cross-sectional, Pelvic Pain, Temporomandibular Joint Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (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 learn whether pain in the temporomandibular joint is associated with pelvic pain in adults, and to explore psychosocial and pain sensitization factors that may contribute to both conditions.
The main questions it aims to answer are:
Is temporomandibular joint dysfunction associated with pelvic pain in the adult population? Are psychosocial factors and indicators of central pain sensitization related to the co-occurrence of these pain conditions?
Participants will complete standardized, self-administered questionnaires at a single point in time that assess:
Temporomandibular joint symptoms Pelvic pain symptoms Psychosocial factors and pain sensitization features
No treatments or interventions will be given as part of this study.
Detailed description
Chronic pain is a major public health concern due to its high prevalence and its significant impact on quality of life, daily functioning, and overall well-being. Among chronic pain types, nociplastic pain is characterized by persistent pain in the absence of clear tissue damage and is associated with alterations in central pain processing, including central sensitization and dysfunction of the central nervous system. These alterations may manifest as widespread pain sensitivity, autonomic dysregulation, and changes in sensory integration, contributing to long-lasting and diffuse pain experiences.
Individuals with chronic pain frequently report pain in more than one body region, a phenomenon known as Chronic Overlapping Pain Conditions (COPC). The presence of overlapping pain conditions suggests shared underlying mechanisms, such as central sensitization and common psychosocial modulators, which may explain the co-occurrence of different chronic pain syndromes. In this context, temporomandibular joint (TMJ) pain and pelvic pain are of particular interest, as emerging evidence indicates a possible association between these conditions.
Given the existing evidence linking chronic pain conditions across different body regions, further investigation into the co-occurrence of TMJ dysfunction and pelvic pain is warranted. This observational, cross-sectional study aims to characterize the association between these two pain conditions in an adult population and to explore demographic, socioeconomic, psychosocial, and pain-related factors that may help explain their relationship. By improving understanding of shared pain mechanisms, this research seeks to inform future clinical approaches that are more comprehensive and integrative.
Data will be collected at a single time point using standardized, self-administered questionnaires, in accordance with the STROBE guidelines for observational research. Demographic variables will include age, sex, and-among female participants-reproductive and hormonal history (pregnancy, childbirth, episiotomy, cesarean section, and menopausal status). Additional variables will include marital status, current medication use, height, weight, smoking status, physical activity levels, and the duration of orofacial and/or pelvic pain symptoms. Socioeconomic factors such as educational level, classified according to the International Standard Classification of Education (ISCED), and monthly household income, categorized into national income deciles, will also be recorded.
The co-occurrence of chronic pain conditions will be assessed using the Chronic Overlapping Pain Conditions Screener (COPC-S). Pain intensity will be measured using the Numerical Rating Scale (NRS), while fear of movement related to orofacial pain will be evaluated using the Tampa Scale of Kinesiophobia adapted for temporomandibular disorders (TSK-TMD). The presence of central sensitization symptoms will be assessed with the Central Sensitization Inventory (CSI). Psychosocial influences on pain will be examined through measures of health-related quality of life (Short Form-12), perceived stress (Perceived Stress Scale-10), and anxiety (short form of the State-Trait Anxiety Inventory, STAI-6).
By systematically examining the overlap between temporomandibular and pelvic pain and their associated biopsychosocial factors, this study aims to provide preliminary evidence on shared mechanisms of chronic pain. The findings may support the development of more holistic assessment strategies and integrated clinical interventions for individuals experiencing chronic overlapping pain conditions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain | – | –Adults with chronic pain who do not report pain in the pelvic region or the temporomandibular joint. |
| Temporomandibular Pain Only | – | –Adults with chronic pain who report pain or dysfunction in the temporomandibular joint region but do not report pelvic pain. |
| Pelvic Pain Only | – | –Adults with chronic pain who report pelvic pain but do not report temporomandibular joint pain. |
| Overlapping Pelvic and Temporomandibular Pain | – | –Adults with chronic pain who report both pelvic pain and temporomandibular joint pain, consistent with chronic overlapping pain conditions. |
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 general population experiencing chronic pain. The study population includes individuals aged 18 years or older who report pain in the orofacial (temporomandibular) region, the pelvic region, both regions, or chronic pain in other body areas without involvement of the temporomandibular or pelvic regions. Participants must be able to read and understand Spanish and provide informed consent.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Presence of chronic pain
- Ability to complete self-administered questionnaires.
- Signed informed consent provided prior to participation.
Key exclusion criteria (2 listed)
- Inability to read or understand Spanish.
- Failure or refusal 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
Co-occurrence of Chronic Pain Conditions
Time frame: Baseline
The presence and degree of overlapping chronic pain conditions will be assessed using the Chronic Overlapping Pain Conditions Screener (COPC-S). This validated tool identifies co-occurring pain conditions across different body regions and will be used to classify participants into pain groups and to quantify overlap between temporomandibular and pelvic pain.
6 secondary outcomes
Pain Intensity
Time frame: Baseline
Kinesiophobia Related to Temporomandibular Pain
Time frame: Baseline
Central Sensitization Symptoms
Time frame: Baseline
Health-Related Quality of Life
Time frame: Baseline
Perceived Stress
Time frame: Baseline
Anxiety Levels
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 7 Jan 2026.
- Individual participant dataSharing planned: No
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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. 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 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 7 Jan 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?
Co-occurrence of Chronic Pain Conditions (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 7 Jan 2026.