Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain

Pelvic Pain Clinical Trial

Official title:

Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02856334
• Other study ID #: 0117
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 20, 2016
• Last updated: August 1, 2016
• Start date: January 2016

Study information

• Verified date: August 2016
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pelvic Pain
• Pudendal Neuralgia
• Pudendal Neuropathy
• Vulvodynia

Locations

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