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

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ClinicalTrials.gov Identifier: NCT02957214
Recruitment Status : Unknown
Verified November 2016 by Rafael Torres Cueco, University of Valencia.
Recruitment status was:  Recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Rafael Torres Cueco, 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

Condition or disease Intervention/treatment Phase
Pelvic Pain Behavioral: Pain education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Experimental: 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.
Behavioral: Pain education



Primary Outcome Measures :
  1. Study Functional Magnetic Resonance Image (fMRI) [ Time Frame: At day 1 ]
    Fractional anisotropy maps 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

  3. Study Functional Magnetic Resonance Image (fMRI) [ Time Frame: At 6 months of completing the education program ]
    Fractional anisotropy maps


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: Day 1 and at 6 months of completing the education program ]
  2. BRIEF PAIN INVENTORY [ Time Frame: Day 1 and at 6 months of completing the education program ]
  3. Survey on Pain Attitudes (SOPA-35) [ Time Frame: Day 1 and at 6 months of completing the education program ]
  4. Graded Chronic Pain Scale [ Time Frame: Day 1 and at 6 months of completing the education program ]
  5. Multidimensional Pain Inventory (MPI) - Interference Scale [ Time Frame: Day 1 and at 6 months of completing the education program ]
  6. Oswestry Disability Index (ODI) [ Time Frame: Day 1 and at 6 months of completing the education program ]
  7. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Day 1 and at 6 months of completing the education program ]
  8. Pain Catastrophizing Scale [ Time Frame: Day 1 and at 6 months of completing the education program ]
  9. Coping Strategies Scale [ Time Frame: Day 1 and at 6 months of completing the education program ]
  10. Tampa Scale for Kinesiophobia-11 [ Time Frame: Day 1 and at 6 months of completing the education program ]
  11. Female Sexual Function Index [ Time Frame: Day 1 and at 6 months of completing the education program ]
  12. Neurocognitive test [ Time Frame: Day 1 and at 6 months of completing the education program ]
    Wechsler Adult Intelligence Scale

  13. Neurocognitive test [ Time Frame: Day 1 and at 6 months of completing the education program ]
    Stroop (colours and words test)

  14. Neurocognitive test [ Time Frame: Day 1 and at 6 months of completing the education program ]
    Wisconsin Card Sorting Test (WCST)

  15. Neurocognitive test [ Time Frame: Day 1 and at 6 months of completing the education program ]
    Iowa Gambling Task

  16. Quantitative Sensory Testing [ Time Frame: Between 7 and 31 days later randomly ]
    Temporal Sumation

  17. Quantitative Sensory Testing [ Time Frame: Between 7 and 31 days later randomly ]
    Conditioned Pain Modulation



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957214


Contacts
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Contact: Rafael Torres-Cueco 609746068 Rafael.Torres@uv.es

Locations
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Spain
Rafael Torres Cueco Recruiting
Valencia, Spain, 46010
Contact: Rafael Torres-Cueco    609746068    Rafael.Torres@uv.es   
Principal Investigator: Rafael Torres-Cueco         
Principal Investigator: Francisco Javier Romero-Gomez         
Sub-Investigator: Luis Martí-Bonmartí         
Sub-Investigator: Gracián García-Martí         
Sub-Investigator: Roberto Sanz-Requena         
Sub-Investigator: Julio Cea-Calvo         
Sub-Investigator: Sandra González-Álvarez         
Sub-Investigator: Francisco J. Nohales-Alfonso         
Sub-Investigator: Enrique Lluch-Girbes         
Sub-Investigator: María del Mar Machirán-Matallín         
Sponsors and Collaborators
University of Valencia
Investigators
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Principal Investigator: Rafael Torres-Cueco

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Responsible Party: Rafael Torres Cueco, PT, University of Valencia
ClinicalTrials.gov Identifier: NCT02957214     History of Changes
Other Study ID Numbers: RM-27072016
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms