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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pelvic Pain; Chronic Perineal Pain
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital
  • Nantes, France, 44277
    • Groupe confluent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient with pelvic or perineal pain with sensitization; Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5)	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.
Other: Patient with pelvic or perineal pain without sensitization; Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria < 5)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): February 14, 2022
• Study Completion (Actual): February 14, 2022

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: pain thresholds; sensitization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: RC17_0427

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No