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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population : a Prospective Controlled Interventional Study

Conditions
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Chronic Pelvic Pain, Chronic Perineal Pain

Intervention / Treatment
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* Other: Sensory testing of lower urinary tract.
* Other: Sensory testing of lower rectal tract
* Other: Sensory testing of vulva muscles
* Other: Sensory testing of pelvic muscles


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient with pelvic or perineal pain with sensitization<br>Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) | Other: Sensory testing of lower urinary tract.<br>* Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds.<br>Other: Sensory testing of lower rectal tract<br>* Lower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension).<br>Other: Sensory testing of vulva muscles<br>* Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.<br>Other: Sensory testing of pelvic muscles<br>* Myofascial sensitivity testing: piriformis, levator ani and obturator internus muscles pressure pain threshold evaluated using intra-vaginal algometer.<br>|
| Other: Patient with pelvic or perineal pain without sensitization<br>Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria < 5) | Other: Sensory testing of lower urinary tract.<br>* Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds.<br>Other: Sensory testing of lower rectal tract<br>* Lower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension).<br>Other: Sensory testing of vulva muscles<br>* Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.<br>Other: Sensory testing of pelvic muscles<br>* Myofascial sensitivity testing: piriformis, levator ani and obturator internus muscles pressure pain threshold evaluated using intra-vaginal algometer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 month after inclusion in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of temporal distribution of pain | Identification of temporal distribution 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). | 1 month after inclusion in the study | 
| Identification of lower pain perception thresholds | Identification of lower pain perception thresholds in women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) compared to women without sensitization (Convergences PP criteria < 5) for each of the 4 neurophysiological testing. | 1 month after inclusion in the study | 
| Comparison of state anxiety | Comparison of state anxiety between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5). | 1 month after inclusion in the study | 
| Comparison of depression | Comparison of depression between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5). | 1 month after inclusion in the study | 
| Comparison of catastrophizing | Comparison of catastrophizing between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5). | 1 month after inclusion in the study | 
| Comparison of quality of life | Comparison of quality of life between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5). | 1 month after inclusion in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensitization, pain thresholds