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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03541954
Acronym
DOPEC
Enrollment
60
Registered
2018-05-31
Start date
2018-07-17
Completion date
2022-02-14
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pelvic Pain, Chronic Perineal Pain

Keywords

sensitization, pain thresholds

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.

Interventions

OTHERSensory testing of lower urinary tract.

Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds.

OTHERSensory testing of lower rectal tract

Lower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension).

OTHERSensory testing of vulva muscles

Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.

OTHERSensory testing of pelvic muscles

Myofascial sensitivity testing: piriformis, levator ani and obturator internus muscles pressure pain threshold evaluated using intra-vaginal algometer.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Intervention model description

2 types of patients will be included: * 30 patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5) * 30 patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Comparison of pelvic pain threshold1 month after inclusion in the studyComparison 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

MeasureTime frameDescription
Identification of lower pain perception thresholds1 month after inclusion in the studyIdentification 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 state anxiety1 month after inclusion in the studyComparison of state anxiety 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 pain1 month after inclusion in the studyIdentification 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 catastrophizing1 month after inclusion in the studyComparison of catastrophizing between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5) and without sensitization (Convergences PP criteria \< 5).
Comparison of quality of life1 month after inclusion in the studyComparison 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).
Comparison of depression1 month after inclusion in the studyComparison of depression between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5) and without sensitization (Convergences PP criteria \< 5).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026