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NCT Number: NCT05637502

Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder

The goal of this clinical trial is to assess the effects of a Graded Motor Imagery (GMI) programme in women diagnosed with Genito-Pelvic Pain Penetration (GPPD) Disorder.

The main questions it aims to answer are:

Does a GMI programme reduce pain intensity levels in women diagnosed with GPPPD? Does a GMI programme have an effect on sexual function in women diagnosed with GPPPD?

Participants will undergo a GMI programme and will be tested prior to and after the intervention to assess if the programme has a significant effect with regards to pain intensity and other pain-related outcome

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Key information

Conditions

Genito-Pelvic Pain/Penetration Disorder Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

About this study

Graded Motor Imagery has been extensively used in several populations suffering pain-related disorders. It triggers cortical stimulation gradually in order to have an effect on the alterations that might have occured due to pain

Women suffering from Genito-Pelvic Pain Penetration Disorder deal with persistent pelvic pain that is no longer responding to a noxious stimulus, therefore this clinical presentation could have several cortical alterations implicated.

The main goal of this study is to assess if a Graded Motor Imagery programme is able to reduce pain intensity and improve sexual function in women diagnosed with Genito-Pelvic Pain Penetration Disorder.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women diagnosed with persistent pelvic pain
  • Pain suffered for a period of a minimum of 3 months
  • Adult (>18 years) women

Exclusion criteria

  • Medical condition that logically explains the presence of pain
  • Pain suffered for a period of less than 3 months

Treatment and study plan

Graded motor imagery

Other

Graded Motor Imagery programme consisting on three stages that will be gradually implemented. (i) Implicit Motor Imagery, that will be implemented through a developed app that resembles the Recognize app but adapted for Pelvic Floor disorders, (ii) Explicit Motor Imagery, applied through several sessions of motor imagery assisted through audio recordings and (iii) Graded Exposure, also guided through audio recordings and several practical tasks to perform.

Primary outcomes

  1. Pain Intensity

    Time frame: 6 weeks

    Pain intensity assessed through a Visual Analogue Scale, with a mininum value of 0 and a maximum value of 10, higher scores mean a worse outcome

  2. Sexual function

    Time frame: 6 weeks

    Sexual function assessed through a short version of the Female Sexual Function Index (FSFI). Minimum score is 6, maximum score is 30. Higher scores mean better outcome.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder. A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2022
Registry last updated
May 10, 2024

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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