Pelvic PainNCT02957214
Effects of an Intervention Program Based on Pain Education in Patients With Chronic Pelvic Pain
A study testing Pain education in people with Pelvic Pain, run by University of Valencia at 1 site in Spain.
Trial summary
The purpose of this study is to obtain imaging biomarkers based on changes in activity patterns and changes in brain connectivity obtained with the analysis of functional magnetic resonance imaging (fMRI) and tractography that are related to chronic pelvic pain Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Pain education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2017to 10 Dec 2019
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 55 years
- Chronic pelvic pain diagnosis
- Pain duration > 6 months
- Average pain intensity ≥ 6 during the previous week
Who cannot join
- Suspected or knowledge of actual organic pathology that requires medical or surgical treatment
- Psychiatric illness: major depression, bipolar syndrome...
- Patients with significant cognitive deficits
- Have pacemaker, metal prostheses or hearing aids incompatible with MRI
- Severe traumatic brain injury
- Previous cranial surgeries
- History of alcoholism
- Do not sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Controlled Study of the Effects of an Intervention Program Based on Pain Education in Pain Activity Patterns and Brain Connectivity in Patients With Chronic Pelvic Pain by Magnetic Resonance Images
The purpose of this study is to obtain imaging biomarkers based on changes in activity patterns and changes in brain connectivity obtained with the analysis of functional magnetic resonance imaging (fMRI) and tractography that are related to chronic pelvic pain
- Conditions
- Pelvic Pain
- Being tested
- Pain education
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain educationOther
Also called pain neuroscience education
The patient education provides a basic set of information that includes the explanation of possible pathophysiological mechanisms involved in the development of chronic pain. The main objective is to reduce pain threatening and alarmist interpretation. The patient must understand that the pain is not necessarily a sign of injury, but the consequence of a maladaptive central sensitization. One element of this therapeutic strategy is to help the patient to perform physical activities that involve a gradual exposition to stimuli associated with their pain and promote physical recovery exposure. Pain education also aims to reduce fear-avoidance behavior and the patient's disability.
| Study group | Role | What they receive |
|---|---|---|
| Pain education | Experimental | The patient education provides a basic set of information that includes the explanation of possible pathophysiological mechanisms involved in the development of chronic pain. The main objective is to reduce pain threatening and alarmist interpretation. The patient must understand that the pain is not necessarily a sign of injury, but the consequence of a maladaptive central sensitization. One element of this therapeutic strategy is to help the patient to perform physical activities that involve a gradual exposition to stimuli associated with their pain and promote physical recovery exposure. Pain education also aims to reduce fear-avoidance behavior and the patient's disability. Receives: Other: Pain education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Functional Magnetic Resonance Image (fMRI)
Fractional anisotropy maps Functional MRI Voxel voxel orientation maps Maps diffusivity Functional study RestingState
Measured: At day 1
Study Functional Magnetic Resonance Image (fMRI)
Fractional anisotropy maps Functional MRI
Measured: Between 7 and 31 days later randomly
Study Functional Magnetic Resonance Image (fMRI)
Fractional anisotropy maps Functional MRI
Measured: At 6 months of completing the education program
Secondary outcomes (7)
numerical rating scale NRS
Measured: Day 1 and at 6 months of completing the education program
Multidimensional Pain Inventory (MPI) - Interference Scale
Measured: Day 1 and at 6 months of completing the education program
Oswestry Disability Index (ODI)
Measured: Day 1 and at 6 months of completing the education program
Hospital Anxiety and Depression Scale (HADS)
Measured: Day 1 and at 6 months of completing the education program
Pain Catastrophizing Scale
Measured: Day 1 and at 6 months of completing the education program
Tampa Scale for Kinesiophobia-11
Measured: Day 1 and at 6 months of completing the education program
Female Sexual Function Index
Measured: Day 1 and at 6 months of completing the education program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start1 May 2017
- Primary completion10 Sep 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Torres Cueco, University of Valencia
- Investigators
- Rafael Torres-Cueco, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957214
- Sponsor's protocol ID
- RM-27072016
- Status last verified
- Jul 2023
- First submitted
- 31 Oct 2016
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Study of the Effects of an Intervention Program Based on Pain Education in Pain Activity Patterns and Brain Connectivity in Patients With Chronic Pelvic Pain by Magnetic Resonance Images
- ClinicalTrials.gov ID
- NCT02957214
- Acronym / sponsor ID
- RM-27072016
- Conditions
- Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 7 Nov 2016 (estimated)
- 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 purpose of this study is to obtain imaging biomarkers based on changes in activity patterns and changes in brain connectivity obtained with the analysis of functional magnetic resonance imaging (fMRI) and tractography that are related to chronic pelvic pain
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain education | Experimental | Other: Pain educationThe patient education provides a basic set of information that includes the explanation of possible pathophysiological mechanisms involved in the development of chronic pain. The main objective is to reduce pain threatening and alarmist interpretation. The patient must understand that the pain is not necessarily a sign of injury, but the consequence of a maladaptive central sensitization. One element of this therapeutic strategy is to help the patient to perform physical activities that involve a gradual exposition to stimuli associated with their pain and promote physical recovery exposure. Pain education also aims to reduce fear-avoidance behavior and the patient's disability. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 55 years
- Chronic pelvic pain diagnosis
- Pain duration > 6 months
- Average pain intensity ≥ 6 during the previous week
Key exclusion criteria (8 listed)
- Suspected or knowledge of actual organic pathology that requires medical or surgical treatment
- Psychiatric illness: major depression, bipolar syndrome...
- Patients with significant cognitive deficits
- Have pacemaker, metal prostheses or hearing aids incompatible with MRI
- Severe traumatic brain injury
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 |
|---|---|---|
| Pain educationAlso: pain neuroscience educationThe patient education provides a basic set of information that includes the explanation of possible pathophysiological mechanisms involved in the development of chronic pain. The main objective is to reduce pain threatening and alarmist interpretation. The patient must understand that the pain is not necessarily a sign of injury, but the consequence of a maladaptive central sensitization. One element of this therapeutic strategy is to help the patient to perform physical activities that involve a gradual exposition to stimuli associated with their pain and promote physical recovery exposure. Pain education also aims to reduce fear-avoidance behavior and the patient's disability. | Other | Pain education |
Primary outcome
Study Functional Magnetic Resonance Image (fMRI)
Time frame: At day 1
Fractional anisotropy maps Functional MRI Voxel voxel orientation maps Maps diffusivity Functional study RestingState
Study Functional Magnetic Resonance Image (fMRI)
Time frame: Between 7 and 31 days later randomly
Fractional anisotropy maps Functional MRI
Study Functional Magnetic Resonance Image (fMRI)
Time frame: At 6 months of completing the education program
Fractional anisotropy maps Functional MRI
7 secondary outcomes
numerical rating scale NRS
Time frame: Day 1 and at 6 months of completing the education program
Multidimensional Pain Inventory (MPI) - Interference Scale
Time frame: Day 1 and at 6 months of completing the education program
Oswestry Disability Index (ODI)
Time frame: Day 1 and at 6 months of completing the education program
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 1 and at 6 months of completing the education program
Pain Catastrophizing Scale
Time frame: Day 1 and at 6 months of completing the education program
Tampa Scale for Kinesiophobia-11
Time frame: Day 1 and at 6 months of completing the education program
Female Sexual Function Index
Time frame: Day 1 and at 6 months of completing the education program
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 1 Aug 2023.
Related trials for Pelvic Pain
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Active, not recruiting
Hypopressive-Core Stabilization With and Without Whole-Body Vibration in Postpartum Pelvic Girdle Pain
Postpartum Pelvic Girdle Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Rafael Torres-Cueco principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain education 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 4 inclusion and 8 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 1 Aug 2023. 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?
Study Functional Magnetic Resonance Image (fMRI) (time frame: At day 1). The study lists 3 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 1 Aug 2023.