Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population

N/ATerminatedNCT03541954

Nantes University Hospital60 enrolled

Overview

The purpose of this study is to assess and validate the clinical criteria of sensitization ("Convergences PP criteria") selected by the expert consensus with neurophysiological sensory testing.

Some patient with chronic pelvic or perineal pain, present complex manifestations, comprising pain and dysfunction which does not involved a single organ. The gap between clinical symptoms and pathological signs is a constant feature of these pain syndromes. A possible explanation for these pain syndromes is central sensitization. This sensitization is defined by decrease nociceptive thresholds, a more intense and more prolonged response to nociceptive stimulus, and spatial extension of the painful area. It has been defined by international expert consensus in 2016 a clinical evaluation tool with 10 criteria for sensitization diagnosis: Convergences PP criteria. The aim of this study is to objectivize lower threshold, spatial and temporal diffusion of pain in women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5) compared to women without sensitization (Convergences PP criteria \< 5). A sensory testing of lower urinary tract, lower rectal tract, vulva and pelvic muscles will be achieved.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Chronic Pelvic Pain Chronic Perineal Pain

Interventions

Sensory testing of lower urinary tract.OTHER

Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds.

Sensory testing of lower rectal tractOTHER

Lower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension).

Sensory testing of vulva musclesOTHER

Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.

Eligibility

Sex: FEMALEMin age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women \> 25 years, * Pelvic or perineal pain since \> 3 months, * No injury in pelvic imagery or clinical examination that may explain all the pain complaint, * Patient who can understand the protocol, * Patient who agreed and signed the informed consent for participation. Exclusion Criteria: * Poor understanding of French language, * Pregnancy or lactation, * Severe depression (Beck Depression Inventory-Short form \> 16), * Initial pain estimation at 10 on numeric analog scale, * Inadequately cooperating, * Isolated dysmenorrhea, * Deep endometriosis with rectal or bladder lesion, * Genital or bladder infection, * Urogenital tumor history, * Anorectal surgery history a type of digestive resection, * Anal stenosis, * Advanced vaginal prolapse (stage 2 on POP-Q scale), * Post-traumatic stress disorder history, * Deprived of liberty (trusteeship, guardianship).

Locations (2)

Nantes university Hospital

Nantes, France

Groupe Confluent

Nantes, France

Outcomes

Primary Outcomes

Comparison of pelvic pain threshold

Comparison of pelvic pain threshold obtained by 4 neurophysiological testing, between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5) and without sensitization (Convergences PP criteria \< 5).