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

Not Applicable

Completed

• Conditions: Pelvic Pain
• Interventions: Other: Pain education

• Registration Number: NCT02957214
• Lead Sponsor: University of Valencia

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-06
• Study Start: 2017-05-01
• Primary Completion: 2019-09-10
• Study Completion: 2019-12-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pain education	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.

Primary Outcome Measures

Name	Time	Method
Study Functional Magnetic Resonance Image (fMRI)	At 6 months of completing the education program	Fractional anisotropy maps Functional MRI

Secondary Outcome Measures

Name	Time	Method
Female Sexual Function Index	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
Multidimensional Pain Inventory (MPI) - Interference Scale	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
numerical rating scale NRS	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

Trial Locations

Locations (1)

Rafael Torres Cueco; 🇪🇸 Valencia, Spain