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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02957214
Enrollment
15
Registered
2016-11-07
Start date
2017-05-01
Completion date
2019-12-10
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Pain

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

Interventions

OTHERPain 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.

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Study Functional Magnetic Resonance Image (fMRI)At day 1Fractional anisotropy maps Functional MRI Voxel voxel orientation maps Maps diffusivity Functional study RestingState

Secondary

MeasureTime frame
Multidimensional Pain Inventory (MPI) - Interference ScaleDay 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
numerical rating scale NRSDay 1 and at 6 months of completing the education program
Tampa Scale for Kinesiophobia-11Day 1 and at 6 months of completing the education program
Female Sexual Function IndexDay 1 and at 6 months of completing the education program
Pain Catastrophizing ScaleDay 1 and at 6 months of completing the education program

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026