Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain

August 1, 2016 updated by: Rafael Torres Cueco, University of Valencia
The purpose of this study is to determine if the psychosocial factors in women with chronic pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors with central sensitization and dysfunctional pain.

Study Overview

Status

Unknown

Conditions

Detailed Description

This study pretends clarify the psychosocial factors presents in women with chronic pelvic pain, and determine if this factors are predisposing, precipitant or of maintenance, through an interview and a series of validated questionnaires. In addition, these findings will be related to the presence of central sensitization, as measured by quantitative sensory testing.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46021
      • Valencia, Spain, 46021
        • Rafael Torres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with chronic pelvic pain

Description

Inclusion Criteria:

  • Age between 18 and 55 years
  • Chronic pelvic pain diagnosis, defined as persistent pain in pelvis related structures
  • Pain duration ≥6 months
  • Average pain intensity ≥3/10 in NRS during the previous week
  • To understand the objectives of the study

Exclusion Criteria:

  • Suspicion or knowledge of current organic pathology that requires medical or surgical treatment
  • Pain as a consequence of surgery known
  • Pending litigation or financial compensation
  • Psychiatric disorders: major depression, bipolar syndrome, etc ..
  • Cognitive difficulties
  • Not sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic pelvic pain
Women with chronic pelvic pain
Control group
Healthy women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Interview on psychosocial factors
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey of Pain Attitudes-35 (SOPA-35)
Time Frame: Day 1
Day 1
Multidimensional Pain Inventory (MPI) - Interference Scale
Time Frame: Day 1
Day 1
Oswestry Disability Index
Time Frame: Day 1
Day 1
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Day 1
Day 1
Pain Catastrophizing Scale
Time Frame: Day 1
Day 1
Coping Strategies Questionnaire (CSQ)
Time Frame: Day 1
Day 1
Tampa Scale for Kinesiophobia (TSK) -11
Time Frame: Day 1
Day 1
Neurophysiology of pain questionnaire (NPQ)
Time Frame: Day 1
Day 1
Female Sexual Function Index (FSFI)
Time Frame: Day 1
Day 1
Patient Specific Functional Scale (PSFS)
Time Frame: Day 1
Day 1
Patient Health Questionnaire (PHQ)
Time Frame: Day 1
Day 1
Quantitative Sensory Testing-Pain Pressure Threshold (PPT)
Time Frame: Day 2
in kg/s
Day 2
Quantitative Sensory Testing-Temporal Summation (TS)
Time Frame: Day 2
in kg/s
Day 2
Quantitative Sensory Testing-Conditioned Pain Modulation (CPM)
Time Frame: Day 2
in kg/s
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Rafael Torres-Cueco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (ESTIMATE)

August 4, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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