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临床试验/NCT07463066
NCT07463066已完成不适用

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.

University of Valencia1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Control group

This group will initially no recieve an intervention and will serve as a control group.

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.

干预措施: In person workshops (Other)

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.

干预措施: Online-accessed material (Other)

结局指标

主要结局

Visual Analogue Scale

时间窗: Baseline

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

次要结局

  • Pain Catastrophizing Scale(Baseline)
  • Survey of Pain Attitudes(Baseline)
  • Female Sexual Function Index(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Borja Pérez-Domínguez

Associate Professor

University of Valencia

研究点 (1)

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