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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Chronic Pelvic Pain; Chronic Perineal Pain

Treatments: Other: Sensory testing of lower rectal tract; Other: Sensory testing of vulva muscles; Other: Sensory testing of pelvic muscles; Other: Sensory testing of lower urinary tract.

Study type: Interventional

Funder types: Other

Identifiers

NCT03541954

RC17_0427

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

Patient with pelvic or perineal pain with sensitization

Other group

Description:

Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5)

Treatment:

Other: Sensory testing of lower urinary tract.

Other: Sensory testing of pelvic muscles

Other: Sensory testing of vulva muscles

Other: Sensory testing of lower rectal tract

Patient with pelvic or perineal pain without sensitization

Other group

Description:

Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)

Treatment:

Other: Sensory testing of lower urinary tract.

Other: Sensory testing of pelvic muscles

Other: Sensory testing of vulva muscles

Other: Sensory testing of lower rectal tract