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Completed

NCT Number: NCT07463066

Long-Term Effectiveness of Pain Neuroscience Education in Women With Genito-Pelvic Pain/Penetration Disorder.

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Physiotherapy. University of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years-old suffering from pelvic pain for more than 6 months

Exclusion criteria

  • Patients suffering from a previous medical condition that explains logically the presence of pain

Treatment and study plan

In person workshops

Other

Several in person workshops given by a researcher

Online-accessed material

Other

Access to a website containing the educational program

Primary outcomes

  1. Numerical Pain Rating Scale

    Time frame: Baseline

    Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome

Secondary outcomes

  1. Pain Catastrophizing Scale

    Time frame: Baseline

    Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome.

  2. Survey of Pain Attitudes

    Time frame: Baseline

    Instrument to understand the pain-related beliefs of your chronic pain patients. Minimum value 0, maximum value 285. Higher scores mean better results.

  3. Female Sexual Function Index

    Time frame: Baseline

    Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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