GMI in Women Suffering GPPPD

• Sponsor: University of Valencia (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05637502
• Collaborator: (none)
• Enrollment: 28
• Arms: 2
• Anticipated Duration (Months): 1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Genito-Pelvic Pain/Penetration Disorder	Other: Graded Motor Imagery; Other: Education	N/A

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 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two parallel group, randomized controlled trialTwo parallel group, randomized controlled trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Graded Motor Imagery in Women Suffering From Genito-Pelvic Pain Penetration Disorder. A Randomized Controlled Trial
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Mar 15, 2023
• Anticipated Study Completion Date: Mar 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Graded Motor Imagery and Education Participants receiving the Graded Motor Imagery programme and a therapeutic educational program	Other: Graded Motor Imagery; 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.; Other: Education; 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.
Active Comparator: Education Participants only receiving a therapeutic educational program	Other: Education; 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.

Outcome Measures

Primary Outcome Measures

1. Pain Intensity [1 week]

   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

Secondary Outcome Measures

1. Cognitions about vaginal penetration [1 week]

   Cognitions about vaginal penetration assessed through the Vaginal Penetration Cognition Questionnaire (VPCQ). Minimum score is 0, maximum score is 240. Higher scores mean a worse outcome.

2. Sexual functioning [1 week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Valencia
• ClinicalTrials.gov Identifier: NCT05637502
• Other Study ID Numbers: Graded Motor Imagery
• First Posted: Dec 5, 2022
• Last Update Posted: Jan 18, 2023
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Valencia: Genito-Pelvic Pain/Penetration Disorder; Pelvic pain; Dyspareunia; Graded Motor Imagery; Physical Therapy
• Additional relevant MeSH terms: Pelvic Pain

Study Results

No Results Posted as of Jan 18, 2023