DOPEC: Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
- 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 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).
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women > 25 years,
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Pelvic or perineal pain since > 3 months,
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No injury in pelvic imagery or clinical examination that may explain all the pain complaint,
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Patient who can understand the protocol,
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Patient who agreed and signed the informed consent for participation.
Exclusion Criteria:
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Poor understanding of French language,
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Pregnancy or lactation,
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Severe depression (Beck Depression Inventory-Short form > 16),
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Initial pain estimation at 10 on numeric analog scale,
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Inadequately cooperating,
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Isolated dysmenorrhea,
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Deep endometriosis with rectal or bladder lesion,
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Genital or bladder infection,
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Urogenital tumor history,
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Anorectal surgery history a type of digestive resection,
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Anal stenosis,
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Advanced vaginal prolapse (stage 2 on POP-Q scale),
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Post-traumatic stress disorder history,
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Deprived of liberty (trusteeship, guardianship).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nantes university Hospital | Nantes | France | 44093 | |
| 2 | Groupe Confluent | Nantes | France | 44277 |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC17_0427