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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02957214
Other study ID # RM-27072016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date December 10, 2019

Study information

Verified date July 2023
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 10, 2019
Est. primary completion date September 10, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pain 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.

Locations

Country Name City State
Spain Rafael Torres Cueco Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Study Functional Magnetic Resonance Image (fMRI) Fractional anisotropy maps Functional MRI Voxel voxel orientation maps Maps diffusivity Functional study RestingState At day 1
Primary Study Functional Magnetic Resonance Image (fMRI) Fractional anisotropy maps Functional MRI Between 7 and 31 days later randomly
Primary Study Functional Magnetic Resonance Image (fMRI) Fractional anisotropy maps Functional MRI At 6 months of completing the education program
Secondary numerical rating scale NRS Day 1 and at 6 months of completing the education program
Secondary Multidimensional Pain Inventory (MPI) - Interference Scale Day 1 and at 6 months of completing the education program
Secondary Oswestry Disability Index (ODI) Day 1 and at 6 months of completing the education program
Secondary Hospital Anxiety and Depression Scale (HADS) Day 1 and at 6 months of completing the education program
Secondary Pain Catastrophizing Scale Day 1 and at 6 months of completing the education program
Secondary Tampa Scale for Kinesiophobia-11 Day 1 and at 6 months of completing the education program
Secondary Female Sexual Function Index Day 1 and at 6 months of completing the education program
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