Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07463066
Brief 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.
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:
NCT07463066
Study Brief:
Protocol Section:
NCT07463066