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

Not Applicable

Completed

• Conditions: Genito-Pelvic Pain/Penetration Disorder
• Interventions: Other: Graded Motor Imagery

• Registration Number: NCT05637502
• Lead Sponsor: University of Valencia

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-12-05
• Study Start: 2023-06-01
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Graded Motor Imagery	Graded Motor Imagery	Participants receiving a tailored Graded Motor Imagery program for pelvic pain.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	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
Sexual function	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.

Trial Locations

Locations (1)

University of Valencia; 🇪🇸 Valencia, Spain