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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain education | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Study Functional Magnetic Resonance Image (fMRI) | Fractional anisotropy maps Functional MRI Voxel voxel orientation maps Maps diffusivity Functional study RestingState | At day 1 |
| Study Functional Magnetic Resonance Image (fMRI) | Fractional anisotropy maps Functional MRI | Between 7 and 31 days later randomly |
| Study Functional Magnetic Resonance Image (fMRI) | Fractional anisotropy maps Functional MRI | At 6 months of completing the education program |
| Measure | Description | Time Frame |
|---|---|---|
| numerical rating scale NRS | Day 1 and at 6 months of completing the education program | |
| Multidimensional Pain Inventory (MPI) - Interference Scale | Day 1 and at 6 months of completing the education program |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Torres-Cueco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rafael Torres Cueco | Valencia | 46010 | Spain |
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| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Oswestry Disability Index (ODI) | Day 1 and at 6 months of completing the education program |
| Hospital Anxiety and Depression Scale (HADS) | Day 1 and at 6 months of completing the education program |
| Pain Catastrophizing Scale | Day 1 and at 6 months of completing the education program |
| Tampa Scale for Kinesiophobia-11 | Day 1 and at 6 months of completing the education program |
| Female Sexual Function Index | Day 1 and at 6 months of completing the education program |