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

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

Study Overview

• Status: Completed
• Conditions: Pelvic Pain
• Intervention / Treatment: Other: Pain education

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafael Torres-Cueco; Phone Number: 609746068; Email: Rafael.Torres@uv.es

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Rafael Torres Cueco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.; Other Names: pain neuroscience education

What is the study measuring?

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	Time Frame
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
numerical rating scale NRS	Day 1 and at 6 months of completing the education program

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Rafael Torres-Cueco

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): September 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimated): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: RM-27072016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No