Effects of an Intervention Program Based on Pain Education in Patients With Chronic Pelvic Pain

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Pelvic Pain

Intervention / Treatment
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* Other: Pain education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 55 years Chronic pelvic pain diagnosis Pain duration > 6 months Average pain intensity ≥ 6 during the previous week Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain education<br>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. | Other: Pain education<br>* 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.<br>* Other names: pain neuroscience education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |