Efficacy of Pain Neuroscience Education in Genito-Pelvic Pain/Penetration Disorder. A Randomized Controlled Trial.

Educational Program Interventions for Patients Suffering From Persistent Pelvic Pain and Their Effects Over Pain and Functionality. A Multi-centered Randomized Clinical Trial.

Patients suffering pelvic persistent pain deal with significant pain that affects their quality of life. Often, conservative treatment interventions are scarce for these patients and are therefore not considered. Education has been developed as a relevant tool in the treatment of patients who suffer from chronic pain or any other pain processing alterations, and has the potential to become a powerfull treatment alternative.

Study Overview

• Status: Completed
• Conditions: Pain; Dysfunction Sexual
• Intervention / Treatment: Other: Workshops; Other: Online-accessed material

Detailed Description

In this intervention, the effects of implementing educational programs in patients suffering from pelvic persistent pain will be assessed.

Patients with pelvic persistent pain have both problems directly related with their pain and other issues that appear derived from suffering pain over a determined period, such as alterations in the sexuality or overall quality of life. Facing these patients is a challenge for professionals, and many can't find the treatment that properly fits the patient's clinical presentation.

Education, and educating patients on their problem, is an exponentially growing alternative used in Physical Therapy involving patients who suffer from a dysfunctional pain, chronic pain, or any kind of pain presentation that affects the patient's well-being.

This study will assess firstly if the implementation of a pain-related education program is relevant in the treatment of pelvic persistent pain, and will further observe which modality (presential workshops or online-accessed material) is the most effective involving adherence and improvement.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over 18 years-old suffering from dyspareunia for more than 3 months

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Workshops; This group will attend face-to-face 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: Workshops; Several face-to-face workshops given by a researcher
Experimental: 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
No Intervention: 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
Visual Analogue Scale	Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome	Baseline to week 4

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 to week 4
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 to week 4
Female Sexual Function Index	Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning	Baseline to week 4

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: UV-INV_ETICA-1741806

Drug and device information, study documents

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