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

Pelvic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957214
• Other study ID #: RM-27072016
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 10, 2019

Study information

• Verified date: July 2023
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Rafael Torres Cueco	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Functional Magnetic Resonance Image (fMRI)	Fractional anisotropy maps Functional MRI Voxel voxel orientation maps Maps diffusivity Functional study RestingState	At day 1
Primary	Study Functional Magnetic Resonance Image (fMRI)	Fractional anisotropy maps Functional MRI	Between 7 and 31 days later randomly
Primary	Study Functional Magnetic Resonance Image (fMRI)	Fractional anisotropy maps Functional MRI	At 6 months of completing the education program
Secondary	numerical rating scale NRS		Day 1 and at 6 months of completing the education program
Secondary	Multidimensional Pain Inventory (MPI) - Interference Scale		Day 1 and at 6 months of completing the education program
Secondary	Oswestry Disability Index (ODI)		Day 1 and at 6 months of completing the education program
Secondary	Hospital Anxiety and Depression Scale (HADS)		Day 1 and at 6 months of completing the education program
Secondary	Pain Catastrophizing Scale		Day 1 and at 6 months of completing the education program
Secondary	Tampa Scale for Kinesiophobia-11		Day 1 and at 6 months of completing the education program
Secondary	Female Sexual Function Index		Day 1 and at 6 months of completing the education program