Genito-Pelvic Pain/Penetration DisorderNCT07463066
Long-Term Effectiveness of Pain Neuroscience Education in Women With Genito-Pelvic Pain/Penetration Disorder.
An observational study of Genito-Pelvic Pain/Penetration Disorder, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this observational follow-up study is to learn whether the benefits of Pain Neuroscience Education are maintained five years after the original intervention in women previously diagnosed with Genito-Pelvic Pain/Penetration Disorder who participated in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genito-Pelvic Pain/Penetration Disorder
- What is being tested?
- In person workshops and Online-accessed material
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2026to 30 Apr 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be selected from the cohort of women previously enrolled in a randomized controlled trial evaluating Pain Neuroscience Education for Genito-Pelvic Pain/Penetration Disorder. The source population consists of adult women diagnosed with Genito-Pelvic Pain/Penetration Disorder who were originally recruited from clinical settings for the parent study. Eligible participants are women 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, marital status, duration of symptoms, pain severity, and baseline functional status. All participants completed the original intervention protocol and will be contacted for long-term follow-up assessment.
Who may be able to join
- Patients over 18 years-old suffering from pelvic pain for more than 6 months
Who cannot join
- Patients suffering from a previous medical condition that explains logically the presence of pain
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: Long-Term Outcomes at Five Years Following Pain Neuroscience Education in Women With Genito-Pelvic Pain/Penetration Disorder: Observational Follow-Up of a Randomized Controlled Trial.
The goal of this observational follow-up study is to learn whether the benefits of Pain Neuroscience Education are maintained five years after the original intervention in women previously diagnosed with Genito-Pelvic Pain/Penetration Disorder who participated in a randomized controlled trial.
The main questions it aims to answer are:
Read more
Are improvements in pain intensity maintained five years after the intervention? Are improvements in sexual function and pain-related disability sustained over time?
Researchers will compare participants according to the treatment group to which they were originally assigned in the randomized controlled trial to evaluate long-term differences in outcomes.
Participants will:
Complete questionnaires assessing pain intensity, sexual function, and pain-related outcomes. Undergo follow-up assessments similar to those performed during the original study.
Read the detailed description
Genito-Pelvic Pain/Penetration Disorder is a chronic pain condition that significantly affects physical, emotional, and sexual well-being. Women experiencing persistent pelvic pain frequently report difficulties related not only to pain intensity but also to sexual function, fear of movement or penetration, and reduced quality of life. Despite its high impact, conservative treatment approaches remain underutilized, and long-term management strategies are still being explored.
Pain Neuroscience Education (PNE) has emerged over the last decade as a therapeutic approach aimed at helping patients understand the neurophysiological mechanisms underlying persistent pain. By reconceptualizing pain as a multifactorial and modifiable process rather than solely a marker of tissue damage, PNE seeks to reduce fear, maladaptive beliefs, and pain-related disability. Growing evidence supports its short- and medium-term effectiveness in various chronic pain populations.
Five years ago, a multi-centered randomized controlled trial evaluated the effectiveness of a structured Pain Neuroscience Education program in women diagnosed with Genito-Pelvic Pain/Penetration Disorder. The intervention was delivered through different educational modalities and demonstrated clinically relevant improvements following treatment.
However, evidence regarding the durability of these effects over extended periods remains limited. Long-term follow-up studies are essential to determine whether educational interventions targeting pain processing produce sustained changes in pain perception, functional outcomes, and overall well-being.
The present study is designed as a long-term observational follow-up of the original randomized controlled trial cohort. No new intervention will be administered. Instead, participants who were previously enrolled will be reassessed five years after completion of the initial intervention in order to evaluate the persistence of treatment-related changes over time.
This study will contribute to understanding the long-term trajectory of women treated with Pain Neuroscience Education for persistent pelvic pain and will help clarify the potential role of educational strategies as durable components of conservative pain management.
- Conditions
- Genito-Pelvic Pain/Penetration Disorder
- Being tested
- In person workshops, Online-accessed material
- Keywords
- Pain, Pelvic pain, Dysfunction sexual
- Medical subject headings
- Pain, Pelvic Pain, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In person workshopsOther
Several in person workshops given by a researcher
Online-accessed materialOther
Access to a website containing the educational program
| Study group | Role | What they receive |
|---|---|---|
| In person workshops | This group will attend in person workshops were the educational program will be developed. These workshops will be available in several sites, and specific care providers will be assigned for each of these sites. Receives: Other: In person workshops | |
| Online-accessed material | This group will be granted online access to a platform were the educational program will be uploaded. They will be given autonomy regarding when to enter the platform and view the content. Receives: Other: Online-accessed material | |
| Control group | This group will initially no recieve an intervention and will serve as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
Measured: Baseline
Secondary outcomes (3)
Pain Catastrophizing Scale
Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome.
Measured: Baseline
Survey of Pain Attitudes
Instrument to understand the pain-related beliefs of your chronic pain patients. Minimum value 0, maximum value 285. Higher scores mean better results.
Measured: Baseline
Female Sexual Function Index
Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Apr 2026
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genito-Pelvic Pain/Penetration DisorderStudies 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
- 69 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
- NCT07463066
- Sponsor's protocol ID
- UV-INV_ETICA-1741806-FU
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes at Five Years Following Pain Neuroscience Education in Women With Genito-Pelvic Pain/Penetration Disorder: Observational Follow-Up of a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07463066
- Acronym / sponsor ID
- UV-INV_ETICA-1741806-FU
- Conditions
- Genito-Pelvic Pain/Penetration Disorder
- Keywords
- Pain, Pelvic pain, Dysfunction sexual
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 10 Mar 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 follow-up study is to learn whether the benefits of Pain Neuroscience Education are maintained five years after the original intervention in women previously diagnosed with Genito-Pelvic Pain/Penetration Disorder who participated in a randomized controlled trial.
The main questions it aims to answer are:
Are improvements in pain intensity maintained five years after the intervention? Are improvements in sexual function and pain-related disability sustained over time?
Researchers will compare participants according to the treatment group to which they were originally assigned in the randomized controlled trial to evaluate long-term differences in outcomes.
Participants will:
Complete questionnaires assessing pain intensity, sexual function, and pain-related outcomes. Undergo follow-up assessments similar to those performed during the original study.
Detailed description
Genito-Pelvic Pain/Penetration Disorder is a chronic pain condition that significantly affects physical, emotional, and sexual well-being. Women experiencing persistent pelvic pain frequently report difficulties related not only to pain intensity but also to sexual function, fear of movement or penetration, and reduced quality of life. Despite its high impact, conservative treatment approaches remain underutilized, and long-term management strategies are still being explored.
Pain Neuroscience Education (PNE) has emerged over the last decade as a therapeutic approach aimed at helping patients understand the neurophysiological mechanisms underlying persistent pain. By reconceptualizing pain as a multifactorial and modifiable process rather than solely a marker of tissue damage, PNE seeks to reduce fear, maladaptive beliefs, and pain-related disability. Growing evidence supports its short- and medium-term effectiveness in various chronic pain populations.
Five years ago, a multi-centered randomized controlled trial evaluated the effectiveness of a structured Pain Neuroscience Education program in women diagnosed with Genito-Pelvic Pain/Penetration Disorder. The intervention was delivered through different educational modalities and demonstrated clinically relevant improvements following treatment.
However, evidence regarding the durability of these effects over extended periods remains limited. Long-term follow-up studies are essential to determine whether educational interventions targeting pain processing produce sustained changes in pain perception, functional outcomes, and overall well-being.
The present study is designed as a long-term observational follow-up of the original randomized controlled trial cohort. No new intervention will be administered. Instead, participants who were previously enrolled will be reassessed five years after completion of the initial intervention in order to evaluate the persistence of treatment-related changes over time.
This study will contribute to understanding the long-term trajectory of women treated with Pain Neuroscience Education for persistent pelvic pain and will help clarify the potential role of educational strategies as durable components of conservative pain management.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In person workshops | – | Other: In person workshopsThis group will attend in person workshops were the educational program will be developed. These workshops will be available in several sites, and specific care providers will be assigned for each of these sites. |
| Online-accessed material | – | Other: Online-accessed materialThis group will be granted online access to a platform were the educational program will be uploaded. They will be given autonomy regarding when to enter the platform and view the content. |
| Control group | – | –This group will initially no recieve an intervention and will serve as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from the cohort of women previously enrolled in a randomized controlled trial evaluating Pain Neuroscience Education for Genito-Pelvic Pain/Penetration Disorder. The source population consists of adult women diagnosed with Genito-Pelvic Pain/Penetration Disorder who were originally recruited from clinical settings for the parent study. Eligible participants are women 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, marital status, duration of symptoms, pain severity, and baseline functional status. All participants completed the original intervention protocol and will be contacted for long-term follow-up assessment.
Key inclusion criteria (1 listed)
- Patients over 18 years-old suffering from pelvic pain for more than 6 months
Key exclusion criteria (1 listed)
- Patients suffering from a previous medical condition that explains logically the presence of pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In person workshopsSeveral in person workshops given by a researcher | Other | In person workshops |
| Online-accessed materialAccess to a website containing the educational program | Other | Online-accessed material |
Primary outcome
Numerical Pain Rating Scale
Time frame: Baseline
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
3 secondary outcomes
Pain Catastrophizing Scale
Time frame: Baseline
Survey of Pain Attitudes
Time frame: Baseline
Female Sexual Function Index
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 22 May 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 Genito-Pelvic Pain/Penetration Disorder, 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 1 inclusion and 1 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 22 May 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?
Numerical Pain Rating Scale (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 22 May 2026.