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

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:

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.

Study Overview

• Status: Completed
• Conditions: Genito-Pelvic Pain/Penetration Disorder
• Intervention / Treatment: Other: Online-accessed material; Other: In person workshops

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 Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46010
      • Faculty of Physiotherapy. University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: In person workshops; Several in person workshops given by a researcher
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.	Other: Online-accessed material; Access to a website containing the educational program
Control group; This group will initially no recieve an intervention and will serve as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating Scale	Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing Scale	Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome.	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.	Baseline
Female Sexual Function Index	Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning.	Baseline

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Pelvic pain; Dysfunction sexual
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pelvic Pain; Sexual Dysfunction, Physiological
• Other Study ID Numbers: UV-INV_ETICA-1741806-FU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No