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

Not Applicable

Terminated

• Conditions: Chronic Perineal Pain; Chronic Pelvic Pain
• Interventions: 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

• Registration Number: NCT03541954
• Lead Sponsor: Nantes University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Study Start: 2018-07-17
• Primary Completion: 2022-02-14
• Study Completion: 2022-02-14
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 60

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with pelvic or perineal pain with sensitization	Sensory testing of lower urinary tract.	Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5)
Patient with pelvic or perineal pain with sensitization	Sensory testing of pelvic muscles	Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5)
Patient with pelvic or perineal pain without sensitization	Sensory testing of vulva muscles	Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)
Patient with pelvic or perineal pain with sensitization	Sensory testing of lower rectal tract	Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5)
Patient with pelvic or perineal pain without sensitization	Sensory testing of pelvic muscles	Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)
Patient with pelvic or perineal pain with sensitization	Sensory testing of vulva muscles	Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5)
Patient with pelvic or perineal pain without sensitization	Sensory testing of lower urinary tract.	Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)
Patient with pelvic or perineal pain without sensitization	Sensory testing of lower rectal tract	Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)

Primary Outcome Measures

Name	Time	Method
Comparison of pelvic pain threshold	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).

Secondary Outcome Measures

Name	Time	Method
Identification of lower pain perception thresholds	1 month after inclusion in the study	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.
Comparison of quality of life	1 month after inclusion in the study	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).
Identification of temporal distribution of pain	1 month after inclusion in the study	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).
Comparison of state anxiety	1 month after inclusion in the study	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).
Comparison of depression	1 month after inclusion in the study	Comparison of depression between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5) and without sensitization (Convergences PP criteria \< 5).
Comparison of catastrophizing	1 month after inclusion in the study	Comparison of catastrophizing between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5) and without sensitization (Convergences PP criteria \< 5).

Trial Locations

Locations (2)

Nantes university Hospital; 🇫🇷 Nantes, France

Groupe Confluent; 🇫🇷 Nantes, France