Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain

• Conditions: Vulvodynia; Pudendal Neuropathy; Pelvic Pain

• Registration Number: NCT02856334
• Lead Sponsor: University of Valencia

Brief Summary

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.

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-07-20
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-01
• Last Update Submitted: 2016-08-01
• Study First Posted: 2016-08-04
• Last Update Posted: 2016-08-04
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interview on psychosocial factors	Day 1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rafael Torres; 🇪🇸 Valencia, Spain