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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Pain education

About this trial

This is an interventional treatment trial for Pelvic Pain

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Rafael Torres Cueco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain education

Arm Description

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.

Outcomes

Primary Outcome Measures

Study Functional Magnetic Resonance Image (fMRI)

Fractional anisotropy maps Functional MRI Voxel voxel orientation maps Maps diffusivity Functional study RestingState

Study Functional Magnetic Resonance Image (fMRI)

Fractional anisotropy maps Functional MRI

Study Functional Magnetic Resonance Image (fMRI)

Fractional anisotropy maps Functional MRI

Secondary Outcome Measures

numerical rating scale NRS

Multidimensional Pain Inventory (MPI) - Interference Scale

Oswestry Disability Index (ODI)

Hospital Anxiety and Depression Scale (HADS)

Pain Catastrophizing Scale

Tampa Scale for Kinesiophobia-11

Female Sexual Function Index

Full Information

NCT ID

NCT02957214

First Posted

October 31, 2016

Last Updated

July 27, 2023

Sponsor

University of Valencia

1. Study Identification

Unique Protocol Identification Number

NCT02957214

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

September 10, 2019 (Actual)

Study Completion Date

December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pain education

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Pain education

Other Intervention Name(s)

pain neuroscience education

Intervention Description

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.

Primary Outcome Measure Information:

Title

Study Functional Magnetic Resonance Image (fMRI)

Description

Fractional anisotropy maps Functional MRI Voxel voxel orientation maps Maps diffusivity Functional study RestingState

Time Frame

At day 1

Title

Study Functional Magnetic Resonance Image (fMRI)

Description

Fractional anisotropy maps Functional MRI

Time Frame

Between 7 and 31 days later randomly

Title

Study Functional Magnetic Resonance Image (fMRI)

Description

Fractional anisotropy maps Functional MRI

Time Frame

At 6 months of completing the education program

Secondary Outcome Measure Information:

Title

numerical rating scale NRS

Time Frame