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Completed

NCT Number: NCT02957214

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

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

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rafael Torres Cueco

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: pain neuroscience education

Primary outcomes

  1. Study Functional Magnetic Resonance Image (fMRI)

    Time frame: At day 1

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

  2. Study Functional Magnetic Resonance Image (fMRI)

    Time frame: Between 7 and 31 days later randomly

    Fractional anisotropy maps Functional MRI

  3. Study Functional Magnetic Resonance Image (fMRI)

    Time frame: At 6 months of completing the education program

    Fractional anisotropy maps Functional MRI

Secondary outcomes

  1. numerical rating scale NRS

    Time frame: Day 1 and at 6 months of completing the education program

  2. Multidimensional Pain Inventory (MPI) - Interference Scale

    Time frame: Day 1 and at 6 months of completing the education program

  3. Oswestry Disability Index (ODI)

    Time frame: Day 1 and at 6 months of completing the education program

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Day 1 and at 6 months of completing the education program

  5. Pain Catastrophizing Scale

    Time frame: Day 1 and at 6 months of completing the education program

  6. Tampa Scale for Kinesiophobia-11

    Time frame: Day 1 and at 6 months of completing the education program

  7. Female Sexual Function Index

    Time frame: Day 1 and at 6 months of completing the education program

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2016
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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