Pelvic PainNCT02856334
Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain
An observational study of Pelvic Pain and Vulvodynia, run by University of Valencia at 2 sites in Spain.
Trial summary
The purpose of this study is to determine if the psychosocial factors in women with chronic pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors with central sensitization and dysfunctional pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Vulvodynia, Pudendal Neuropathy
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2016to Dec 2016
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with chronic pelvic pain
Who may be able to join
- Age between 18 and 55 years
- Chronic pelvic pain diagnosis, defined as persistent pain in pelvis related structures
- Pain duration ≥6 months
- Average pain intensity ≥3/10 in NRS during the previous week
- To understand the objectives of the study
Who cannot join
- Suspicion or knowledge of current organic pathology that requires medical or surgical treatment
- Pain as a consequence of surgery known
- Pending litigation or financial compensation
- Psychiatric disorders: major depression, bipolar syndrome, etc ..
- Cognitive difficulties
- Not sign the informed consent
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Rafael Torres
Valencia, Valencia, 46021
Study site
Valencia, Valencia, 46021
About this study
The purpose of this study is to determine if the psychosocial factors in women with chronic pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors with central sensitization and dysfunctional pain.
Read the detailed description
This study pretends clarify the psychosocial factors presents in women with chronic pelvic pain, and determine if this factors are predisposing, precipitant or of maintenance, through an interview and a series of validated questionnaires. In addition, these findings will be related to the presence of central sensitization, as measured by quantitative sensory testing.
- Conditions
- Pelvic Pain, Vulvodynia, Pudendal Neuropathy
- Keywords
- chronic pelvic pain, vulvodynia, pelvic pain, psychosocial factors, central sensitization
- Medical subject headings
- Pelvic Pain, Vulvodynia, Pudendal Neuralgia
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 pelvic pain | Women with chronic pelvic pain | |
| Control group | Healthy women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview on psychosocial factors
Measured: Day 1
Secondary outcomes (14)
Survey of Pain Attitudes-35 (SOPA-35)
Measured: Day 1
Multidimensional Pain Inventory (MPI) - Interference Scale
Measured: Day 1
Oswestry Disability Index
Measured: Day 1
Hospital Anxiety and Depression Scale (HADS)
Measured: Day 1
Pain Catastrophizing Scale
Measured: Day 1
Coping Strategies Questionnaire (CSQ)
Measured: Day 1
Tampa Scale for Kinesiophobia (TSK) -11
Measured: Day 1
Neurophysiology of pain questionnaire (NPQ)
Measured: Day 1
Female Sexual Function Index (FSFI)
Measured: Day 1
Patient Specific Functional Scale (PSFS)
Measured: Day 1
Patient Health Questionnaire (PHQ)
Measured: Day 1
Quantitative Sensory Testing-Pain Pressure Threshold (PPT)
in kg/s
Measured: Day 2
Quantitative Sensory Testing-Temporal Summation (TS)
in kg/s
Measured: Day 2
Quantitative Sensory Testing-Conditioned Pain Modulation (CPM)
in kg/s
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Torres Cueco, University of Valencia
- Investigators
- Rafael Torres-Cueco, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856334
- Sponsor's protocol ID
- 0117
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT02856334
- Acronym / sponsor ID
- 0117
- Conditions
- Pelvic Pain, Vulvodynia, Pudendal Neuropathy
- Keywords
- chronic pelvic pain, vulvodynia, pelvic pain, psychosocial factors, central sensitization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- 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 purpose of this study is to determine if the psychosocial factors in women with chronic pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors with central sensitization and dysfunctional pain.
Detailed description
This study pretends clarify the psychosocial factors presents in women with chronic pelvic pain, and determine if this factors are predisposing, precipitant or of maintenance, through an interview and a series of validated questionnaires. In addition, these findings will be related to the presence of central sensitization, as measured by quantitative sensory testing.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic pelvic pain | – | –Women with chronic pelvic pain |
| Control group | – | –Healthy women |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with chronic pelvic pain
Key inclusion criteria (5 listed)
- Age between 18 and 55 years
- Chronic pelvic pain diagnosis, defined as persistent pain in pelvis related structures
- Pain duration ≥6 months
- Average pain intensity ≥3/10 in NRS during the previous week
- To understand the objectives of the study
Key exclusion criteria (6 listed)
- Suspicion or knowledge of current organic pathology that requires medical or surgical treatment
- Pain as a consequence of surgery known
- Pending litigation or financial compensation
- Psychiatric disorders: major depression, bipolar syndrome, etc ..
- Cognitive difficulties
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
Interview on psychosocial factors
Time frame: Day 1
14 secondary outcomes
Survey of Pain Attitudes-35 (SOPA-35)
Time frame: Day 1
Multidimensional Pain Inventory (MPI) - Interference Scale
Time frame: Day 1
Oswestry Disability Index
Time frame: Day 1
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 1
Pain Catastrophizing Scale
Time frame: Day 1
Coping Strategies Questionnaire (CSQ)
Time frame: Day 1
Tampa Scale for Kinesiophobia (TSK) -11
Time frame: Day 1
Neurophysiology of pain questionnaire (NPQ)
Time frame: Day 1
Female Sexual Function Index (FSFI)
Time frame: Day 1
Patient Specific Functional Scale (PSFS)
Time frame: Day 1
Patient Health Questionnaire (PHQ)
Time frame: Day 1
Quantitative Sensory Testing-Pain Pressure Threshold (PPT)
Time frame: Day 2
Quantitative Sensory Testing-Temporal Summation (TS)
Time frame: Day 2
Quantitative Sensory Testing-Conditioned Pain Modulation (CPM)
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
Rafael Torres-Cueco principal investigator
2 sites 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 and Vulvodynia, run by University of Valencia at 2 sites 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Interview on psychosocial factors (time frame: Day 1). 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 4 Aug 2016.