Genito-Pelvic Pain/Penetration DisorderNCT05637502
Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder
A study testing Graded Motor Imagery in people with Genito-Pelvic Pain/Penetration Disorder, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genito-Pelvic Pain/Penetration Disorder
- What is being tested?
- Graded Motor Imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 22 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with persistent pelvic pain
- Pain suffered for a period of a minimum of 3 months
- Adult (>18 years) women
Who cannot join
- Medical condition that logically explains the presence of pain
- Pain suffered for a period of less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder. A Randomized Controlled Trial
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
Read the 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.
- Conditions
- Genito-Pelvic Pain/Penetration Disorder
- Being tested
- Graded Motor Imagery
- Keywords
- Genito-Pelvic Pain/Penetration Disorder, Pelvic pain, Dyspareunia, Graded Motor Imagery, Physical Therapy
- Medical subject headings
- Pelvic Pain, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Motor ImageryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Graded Motor Imagery | Experimental | Participants receiving a tailored Graded Motor Imagery program for pelvic pain. Receives: Other: Graded Motor Imagery |
| Control | No intervention | Participants initially receiving no intervention at all. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Sexual function
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Jun 2023
- Primary completion15 Jul 2023
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genito-Pelvic Pain/Penetration DisorderStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borja Pérez-Domínguez, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637502
- Sponsor's protocol ID
- UV-INV_ETICA-2678233
- Status last verified
- May 2024
- First submitted
- 23 Nov 2022
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05637502
- Acronym / sponsor ID
- UV-INV_ETICA-2678233
- Conditions
- Genito-Pelvic Pain/Penetration Disorder
- Keywords
- Genito-Pelvic Pain/Penetration Disorder, Pelvic pain, Dyspareunia, Graded Motor Imagery, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Graded Motor Imagery | Experimental | Other: Graded Motor ImageryParticipants receiving a tailored Graded Motor Imagery program for pelvic pain. |
| Control | No intervention | –Participants initially receiving no intervention at all. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women diagnosed with persistent pelvic pain
- Pain suffered for a period of a minimum of 3 months
- Adult (>18 years) women
Key exclusion criteria (2 listed)
- Medical condition that logically explains the presence of pain
- Pain suffered for a period of less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded Motor ImageryGraded 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 | Graded Motor Imagery |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Motor Imagery in people with Genito-Pelvic Pain/Penetration Disorder, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.