Clinical trial NCT03541954: Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population
Official title: Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population : a Prospective Controlled Interventional Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pelvic Pain
Chronic Perineal Pain
Keywords: sensitization
pain thresholds
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 types of patients will be included:

* 30 patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5)
* 30 patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Comparison of pelvic pain threshold
timeFrame: 1 month after inclusion in the study
Secondary outcomes:
measure: Identification of temporal distribution of pain
timeFrame: 1 month after inclusion in the study
measure: Identification of lower pain perception thresholds
timeFrame: 1 month after inclusion in the study
measure: Comparison of state anxiety
timeFrame: 1 month after inclusion in the study
measure: Comparison of depression
timeFrame: 1 month after inclusion in the study
measure: Comparison of catastrophizing
timeFrame: 1 month after inclusion in the study
measure: Comparison of quality of life
timeFrame: 1 month after inclusion in the study
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes university Hospital
city: Nantes
country: France
facility: Groupe Confluent
Study officials:
References: