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

University of Valencia1 site in 1 country15 target enrollmentMay 1, 2017

ConditionsPelvic Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pelvic Pain
Sponsor: University of Valencia
Enrollment: 15
Locations: 1
Primary Endpoint: Study Functional Magnetic Resonance Image (fMRI)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

May 1, 2017

End Date

December 10, 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Valencia

Responsible Party

Principal Investigator

Rafael Torres Cueco

University of Valencia

Eligibility Criteria

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

Outcomes

Primary Outcomes

Study Functional Magnetic Resonance Image (fMRI)

Time Frame: At 6 months of completing the education program

Fractional anisotropy maps Functional MRI

Secondary Outcomes

Oswestry Disability Index (ODI)(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)
Hospital Anxiety and Depression Scale (HADS)(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)
Pain Catastrophizing Scale(Day 1 and at 6 months of completing the education program)
numerical rating scale NRS(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)