PainNCT05114473
Efficacy of Pain Neuroscience Education in Genito-Pelvic Pain/Penetration Disorder. A Randomized Controlled Trial.
A study testing Workshops and Online-accessed material in people with Pain and Dysfunction Sexual, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Dysfunction Sexual
- What is being tested?
- Workshops and Online-accessed material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 10 Dec 2021to 21 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients over 18 years-old suffering from dyspareunia for more than 3 months
Who cannot join
- Patients suffering from a previous medical condition that explains logically the presence of pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Program Interventions for Patients Suffering From Persistent Pelvic Pain and Their Effects Over Pain and Functionality. A Multi-centered Randomized Clinical Trial.
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.
Read the detailed description
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
- Pain, Dysfunction Sexual
- Being tested
- Workshops, Online-accessed material
- Medical subject headings
- Pain, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkshopsOther
Several face-to-face workshops given by a researcher
Online-accessed materialOther
Access to a website containing the educational program
| Study group | Role | What they receive |
|---|---|---|
| Workshops | Experimental | 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. Receives: Other: Workshops |
| Online-accessed material | Experimental | 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. Receives: Other: Online-accessed material |
| Control group | No intervention | This group will initially no recieve an intervention and will serve as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
Measured: Baseline to week 4
Secondary outcomes (3)
Pain Catastrophizing Scale
Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome
Measured: Baseline to week 4
Survey of Pain Attitudes
Instrument to understand the pain-related beliefs of your chronic pain patients. Minimum value 0, maximum value 285. Higher scores mean better results
Measured: Baseline to week 4
Female Sexual Function Index
Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning
Measured: Baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start10 Dec 2021
- Primary completion28 Feb 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies 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
- Two groups receiving intervention and one serving as control
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 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
- NCT05114473
- Sponsor's protocol ID
- UV-INV_ETICA-1741806
- Status last verified
- Apr 2025
- First submitted
- 25 Oct 2021
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Program Interventions for Patients Suffering From Persistent Pelvic Pain and Their Effects Over Pain and Functionality. A Multi-centered Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05114473
- Acronym / sponsor ID
- UV-INV_ETICA-1741806
- Conditions
- Pain, Dysfunction Sexual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Posted 23 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Two groups receiving intervention and one serving as control
| Arm | Type | Receives |
|---|---|---|
| Workshops | Experimental | Other: WorkshopsThis 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. |
| Online-accessed material | Experimental | Other: Online-accessed materialThis 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. |
| Control group | No intervention | –This group will initially no recieve an intervention and will serve as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years-old suffering from dyspareunia for more than 3 months
Key exclusion criteria (1 listed)
- Patients suffering from a previous medical condition that explains logically the presence of pain
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 |
|---|---|---|
| WorkshopsSeveral face-to-face workshops given by a researcher | Other | Workshops |
| Online-accessed materialAccess to a website containing the educational program | Other | Online-accessed material |
Primary outcome
Visual Analogue Scale
Time frame: Baseline to week 4
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
3 secondary outcomes
Pain Catastrophizing Scale
Time frame: Baseline to week 4
Survey of Pain Attitudes
Time frame: Baseline to week 4
Female Sexual Function Index
Time frame: Baseline to week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Workshops and Online-accessed material in people with Pain and Dysfunction Sexual, 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 1 inclusion and 1 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 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 23 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analogue Scale (time frame: Baseline to week 4). 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 Apr 2025.