Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population : a Prospective Controlled Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Comparison of pelvic pain threshold
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Comparison of pelvic pain threshold
时间窗: 1 month after inclusion in the study
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).
次要结局
- Identification of lower pain perception thresholds(1 month after inclusion in the study)
- Identification of temporal distribution of pain(1 month after inclusion in the study)
- Comparison of state anxiety(1 month after inclusion in the study)
- Comparison of depression(1 month after inclusion in the study)
- Comparison of quality of life(1 month after inclusion in the study)
- Comparison of catastrophizing(1 month after inclusion in the study)