Clinical trial NCT02856334: Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain
Official title: Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Pain
Vulvodynia
Pudendal Neuropathy
Keywords: chronic pelvic pain
vulvodynia
pelvic pain
psychosocial factors
central sensitization
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with chronic pelvic pain

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interview on psychosocial factors
timeFrame: Day 1
Secondary outcomes:
measure: Survey of Pain Attitudes-35 (SOPA-35)
timeFrame: Day 1
measure: Multidimensional Pain Inventory (MPI) - Interference Scale
timeFrame: Day 1
measure: Oswestry Disability Index
timeFrame: Day 1
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 1
measure: Pain Catastrophizing Scale
timeFrame: Day 1
measure: Coping Strategies Questionnaire (CSQ)
timeFrame: Day 1
measure: Tampa Scale for Kinesiophobia (TSK) -11
timeFrame: Day 1
measure: Neurophysiology of pain questionnaire (NPQ)
timeFrame: Day 1
measure: Female Sexual Function Index (FSFI)
timeFrame: Day 1
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Day 1
measure: Patient Health Questionnaire (PHQ)
timeFrame: Day 1
measure: Quantitative Sensory Testing-Pain Pressure Threshold (PPT)
timeFrame: Day 2
measure: Quantitative Sensory Testing-Temporal Summation (TS)
timeFrame: Day 2
measure: Quantitative Sensory Testing-Conditioned Pain Modulation (CPM)
timeFrame: Day 2
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Rafael Torres
city: Valencia
country: Spain
Study officials:
name: Rafael Torres-Cueco
role: PRINCIPAL_INVESTIGATOR
References: