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

NCT02957214 | Completed

• 1 other identifier: RM-27072016
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (1)

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.

Other: Pain education

Interventions

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.

Also known as: pain neuroscience education

Pain education

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 55 years
• Chronic pelvic pain diagnosis
• Pain duration \> 6 months
• Average pain intensity ≥ 6 during the previous week

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Rafael Torres Cueco

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rafael Torres-Cueco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 7, 2016
• Study Start: May 1, 2017
• Primary Completion: September 10, 2019
• Study Completion: December 10, 2019
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

ES (1)