NCT03541954

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pelvic Pain
• Chronic Perineal Pain

Interventions

Type	Name	Description
OTHER	Sensory testing of lower urinary tract.	Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds.
OTHER	Sensory testing of lower rectal tract	Lower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension).
OTHER	Sensory testing of vulva muscles	Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.
OTHER	Sensory testing of pelvic muscles	Myofascial sensitivity testing: piriformis, levator ani and obturator internus muscles pressure pain threshold evaluated using intra-vaginal algometer.

Timeline

• Start date: 2018-07-17
• Primary completion: 2022-02-14
• Completion: 2022-02-14
• First posted: 2018-05-31
• Last updated: 2022-04-05

Locations

2 sites across 1 country: France