Efficacy of Pain Neuroscience Education in Genito-Pelvic Pain/Penetration Disorder. A Randomized Controlled Trial.

NCT ID: NCT05114473

Last Updated: 2025-04-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2022-03-21

Brief Summary

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Patients suffering pelvic persistent pain deal with significant pain that affects their quality of life. Often, conservative treatment interventions are scarce for these patients and are therefore not considered. Education has been developed as a relevant tool in the treatment of patients who suffer from chronic pain or any other pain processing alterations, and has the potential to become a powerfull treatment alternative.

Detailed Description

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In this intervention, the effects of implementing educational programs in patients suffering from pelvic persistent pain will be assessed.

Patients with pelvic persistent pain have both problems directly related with their pain and other issues that appear derived from suffering pain over a determined period, such as alterations in the sexuality or overall quality of life. Facing these patients is a challenge for professionals, and many can't find the treatment that properly fits the patient's clinical presentation.

Education, and educating patients on their problem, is an exponentially growing alternative used in Physical Therapy involving patients who suffer from a dysfunctional pain, chronic pain, or any kind of pain presentation that affects the patient's well-being.

This study will assess firstly if the implementation of a pain-related education program is relevant in the treatment of pelvic persistent pain, and will further observe which modality (presential workshops or online-accessed material) is the most effective involving adherence and improvement.

Conditions

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Pain Dysfunction Sexual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups receiving intervention and one serving as control
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
Due to the nature of the intervention, participants can't be blinded to allocation, but are strongly inculcated not to disclose the allocation their status at the follow up assessments. Care providers will be different from outcome assessors and will be both blinded by an external investigator.

Study Groups

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Workshops

This group will attend face-to-face workshops were the educational program will be developed. These workshops will be available in several sites, and specific care providers will be assigned for each of these sites.

Group Type EXPERIMENTAL

Workshops

Intervention Type OTHER

Several face-to-face workshops given by a researcher

Online-accessed material

This group will be granted online access to a platform were the educational program will be uploaded. They will be given autonomy regarding when to enter the platform and view the content.

Group Type EXPERIMENTAL

Online-accessed material

Intervention Type OTHER

Access to a website containing the educational program

Control group

This group will initially no recieve an intervention and will serve as a control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Workshops

Several face-to-face workshops given by a researcher

Intervention Type OTHER

Online-accessed material

Access to a website containing the educational program

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years-old suffering from dyspareunia for more than 3 months

Exclusion Criteria

* Patients suffering from a previous medical condition that explains logically the presence of pain
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Borja Pérez-Domínguez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physical Therapy

Valencia, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UV-INV_ETICA-1741806

Identifier Type: -

Identifier Source: org_study_id

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