GMI in Women Suffering GPPPD

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess the effects of a Graded Motor Imagery (GMI) programme in women suffering from Genito-Pelvic Pain Penetration (GPPD) Disorder. The main questions it aims to answer are: Does a GMI programme reduce pain intensity levels in women suffering GPPPD? Does a GMI programme have an effect on other pain-related outcomes in women suffering 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

Detailed Description
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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 in women suffering from Genito-Pelvic Pain Penetration Disorder. Secondary objectives will include if this programme also improves pain-related outcomes such as pain catastrophizing or pain-related fear of movement, known as kinesiophobia

Official Title
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Graded Motor Imagery in Women Suffering From Genito-Pelvic Pain Penetration Disorder. A Randomized Controlled Trial

Conditions
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Genito-Pelvic Pain/Penetration Disorder

Intervention / Treatment
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* Other: Graded Motor Imagery
* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women suffering from 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 Underage women (<18 years)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two parallel group, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Graded Motor Imagery and Education<br>Participants receiving the Graded Motor Imagery programme and a therapeutic educational program | Other: Graded Motor Imagery<br>* 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.<br>Other: Education<br>* Participants will receive a therapeutic educational programme specifically developed for Genito-Pelvic Pain Penetration Disorder. The programme will include content involving Pelvic Floor anatomy, pain-processing and sexuality discussions.<br>|
| Active Comparator: Education<br>Participants only receiving a therapeutic educational program | Other: Education<br>* Participants will receive a therapeutic educational programme specifically developed for Genito-Pelvic Pain Penetration Disorder. The programme will include content involving Pelvic Floor anatomy, pain-processing and sexuality discussions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | 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 | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual functioning | Sexual Functioning 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. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genito-Pelvic Pain/Penetration Disorder, Pelvic pain, Dyspareunia, Graded Motor Imagery, Physical Therapy