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

Chronic Pelvic Pain Clinical Trial

— DOPEC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03541954
• Other study ID #: RC17_0427
• Status: Terminated
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: February 14, 2022

Study information

• Verified date: March 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Chronic Perineal Pain
• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
France	Groupe Confluent	Nantes
France	Nantes university Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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