Pelvic PainNCT06343649
Response in Patients with Persistent Pelvic Pain to Motor Imagery Through Auditory or Visual Input. a Pilot Randomized Trial.
A study testing Visual and Auditory in people with Pelvic Pain, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this clinical trial is to compare the response of Explicit Motor Imagery interventions in patients suffering Persistent Pelvic Pain. The main question it aims to answer is: Does the modality of application of Explicit Motor Imagery, either through visual or auditory stimuli, influence the response in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Visual and Auditory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 30 Nov 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experience persistent pain for a minimum duration of six months.
- Achieve a minimum score of six points on the Chronic Pelvic Pain Questionnaire (CPPQ), a validated instrument designed to assess the discrimination of pain.
Who cannot join
- Participants with a medically diagnosed condition that logically accounts for the presence of pain during the aforementioned six-month period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Response in Patients with Persistent Pelvic Pain to Explicit Motor Imagery Through Auditory or Visual Input
The goal of this clinical trial is to compare the response of Explicit Motor Imagery interventions in patients suffering Persistent Pelvic Pain. The main question it aims to answer is:
- Does the modality of application of Explicit Motor Imagery, either through visual or auditory stimuli, influence the response in patients suffering Persistent Pelvic Pain?
Read more
Participants will receive an online Explicit Motor Imagery program either through visual inputs or auditory inputs. They will be instructed to follow the program en register their response.
Researchers will compare visual Explicit Motor Imagery and auditory Explicit Motor Imagery to see if different inputs generate different responses in patients suffering Persistent Pelvic Pain.
- Conditions
- Pelvic Pain
- Being tested
- Visual, Auditory
- Keywords
- pain, pelvic pain
- Medical subject headings
- Pelvic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisualOther
Delivery of images to conduct several exercises of Explicit Motor Imagery
AuditoryOther
Delivery of audio recordings to conduct several exercises of Explicit Motor Imagery
| Study group | Role | What they receive |
|---|---|---|
| Visual Explicit Motor Imagery | Experimental | 6 exercises of Explicit Motor Imagery, administered on alternate days, using visual inputs in the form of images. Receives: Other: Visual |
| Auditory Explicit Motor Imagery | Experimental | 6 exercises of Explicit Motor Imagery, administered on alternate days, using auditory inputs in the form of audio recordings. Receives: Other: Auditory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Self-administered scale that requires the patient to rate their pain intensity on a 0-10 scale, where 0 is no pain and 10 is the worst pain imaginable. Higher scores indicate worse outcomes.
Measured: Baseline to two weeks
Pain Vigilance and Awareness Questionnaire
Self-administered questionnaire to measure attention to pain. 16- item questionnaire, where each item is scored as a six- point Likert scale that ranges from zero (never) to five (always), resulting in a sum score between zero and 80. Higher scores indicate worse outcomes.
Measured: Baseline to two weeks
Secondary outcomes (1)
Movement Imagery Questionnaire-Revised
Assesses visual and kinesthetic movement imagery abilities. Self-adminstered instrument comprised of 2 subscales: Visual Imagery (4 items) and Kinesthetic Imagery (4 items). Respondents assign a value from a 7-point scale, which indicates the ease or difficulty with which the movement was seen/felt. Higher scores indicate worse movement imagery abilities.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Nov 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 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
- NCT06343649
- Sponsor's protocol ID
- CEUMA 187-2023-H
- Status last verified
- Jan 2025
- First submitted
- 26 Mar 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perez-Dominguez B, Arce-Elorza A, Rubio-Garcia I, Diaz-Mohedo E. Response in Patients With Persistent Pelvic Pain to Motor Imagery Through Auditory or Visual Input-A Pilot Randomized Trial. Pain Res Manag. 2025 Feb 10;2025:1412626. doi: 10.1155/prm/1412626. eCollection 2025.
PubMed 39963311
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response in Patients with Persistent Pelvic Pain to Explicit Motor Imagery Through Auditory or Visual Input
- ClinicalTrials.gov ID
- NCT06343649
- Acronym / sponsor ID
- CEUMA 187-2023-H
- Conditions
- Pelvic Pain
- Keywords
- pain, pelvic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Apr 2024 (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 compare the response of Explicit Motor Imagery interventions in patients suffering Persistent Pelvic Pain. The main question it aims to answer is:
- Does the modality of application of Explicit Motor Imagery, either through visual or auditory stimuli, influence the response in patients suffering Persistent Pelvic Pain?
Participants will receive an online Explicit Motor Imagery program either through visual inputs or auditory inputs. They will be instructed to follow the program en register their response.
Researchers will compare visual Explicit Motor Imagery and auditory Explicit Motor Imagery to see if different inputs generate different responses in patients suffering Persistent Pelvic Pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Explicit Motor Imagery | Experimental | Other: Visual6 exercises of Explicit Motor Imagery, administered on alternate days, using visual inputs in the form of images. |
| Auditory Explicit Motor Imagery | Experimental | Other: Auditory6 exercises of Explicit Motor Imagery, administered on alternate days, using auditory inputs in the form of audio recordings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Experience persistent pain for a minimum duration of six months.
- Achieve a minimum score of six points on the Chronic Pelvic Pain Questionnaire (CPPQ), a validated instrument designed to assess the discrimination of pain.
Key exclusion criteria (1 listed)
- Participants with a medically diagnosed condition that logically accounts for the presence of pain during the aforementioned six-month period
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 |
|---|---|---|
| VisualDelivery of images to conduct several exercises of Explicit Motor Imagery | Other | Visual Explicit Motor Imagery |
| AuditoryDelivery of audio recordings to conduct several exercises of Explicit Motor Imagery | Other | Auditory Explicit Motor Imagery |
Primary outcome
Numerical Rating Scale
Time frame: Baseline to two weeks
Self-administered scale that requires the patient to rate their pain intensity on a 0-10 scale, where 0 is no pain and 10 is the worst pain imaginable. Higher scores indicate worse outcomes.
Pain Vigilance and Awareness Questionnaire
Time frame: Baseline to two weeks
Self-administered questionnaire to measure attention to pain. 16- item questionnaire, where each item is scored as a six- point Likert scale that ranges from zero (never) to five (always), resulting in a sum score between zero and 80. Higher scores indicate worse outcomes.
1 secondary outcome
Movement Imagery Questionnaire-Revised
Time frame: Baseline
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 20 Jan 2025.
- Derived from this study: PubMed 39963311Perez-Dominguez B, Arce-Elorza A, Rubio-Garcia I, Diaz-Mohedo E. Response in Patients With Persistent Pelvic Pain to Motor Imagery Through Auditory or Visual Input-A Pilot Randomized Trial. Pain Res Manag. 2025 Feb 10;2025:1412626. doi: 10.1155/prm/1412626. eCollection 2025.
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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 Visual and Auditory in people with Pelvic Pain, 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 2 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 20 Jan 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?
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?
Numerical Rating Scale (time frame: Baseline to two 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?
On the ClinicalTrials.gov record for NCT06343649, which also lists 1 linked publication.
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 20 Jan 2025.