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Completed

NCT Number: NCT05114473

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

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Key information

Conditions

Pain Dysfunction Sexual Genital Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Valencia, 46010, Spain

About this study

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.

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 dyspareunia for more than 3 months

Exclusion criteria

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

Treatment and study plan

Workshops

Other

Several face-to-face workshops given by a researcher

Online-accessed material

Other

Access to a website containing the educational program

Primary outcomes

  1. Visual Analogue Scale

    Time frame: Baseline to week 4

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

Secondary outcomes

  1. Pain Catastrophizing Scale

    Time frame: Baseline to week 4

    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 to week 4

    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 to week 4

    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

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2021
Registry last updated
Apr 10, 2025

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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