Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population (DOPEC)
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| ClinicalTrials.gov Identifier: NCT03541954 |
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Recruitment Status :
Recruiting
First Posted : May 31, 2018
Last Update Posted : April 21, 2021
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Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
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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 |
|---|---|---|
| Chronic Pelvic Pain Chronic Perineal Pain | 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 | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 2 types of patients will be included:
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| Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Basic Science |
| Official Title: | Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population : a Prospective Controlled Interventional Study |
| Actual Study Start Date : | July 17, 2018 |
| Estimated Primary Completion Date : | December 17, 2021 |
| Estimated Study Completion Date : | December 17, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Patient with pelvic or perineal pain with sensitization
Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5)
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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. |
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Patient with pelvic or perineal pain without sensitization
Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria < 5)
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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. |
Primary Outcome Measures :
- Comparison of pelvic pain threshold [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
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| Ages Eligible for Study: | 25 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541954
Contacts
| Contact: Stephane PLOTEAU, Doctor | +33 2 40 08 76 84 | stephane.ploteau@chu-nantes.fr | |
| Contact: Claire CARDAILLAC, Medical Student | cardaillac.c@gmail.com |
Locations
| France | |
| Nantes university Hospital | Recruiting |
| Nantes, France, 44093 | |
| Contact: Stéphane PLOTEAU, Doctor +33 2 40 08 76 84 stephane.ploteau@chu-nantes.fr | |
| Contact: claire cardaillac cardaillac.c@gmail.com | |
| Groupe Confluent | Recruiting |
| Nantes, France, 44277 | |
| Contact: Thibault RIANT, Doctor thibault.riant@groupeconfluent.fr | |
Sponsors and Collaborators
Nantes University Hospital
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT03541954 |
| Other Study ID Numbers: |
RC17_0427 |
| First Posted: | May 31, 2018 Key Record Dates |
| Last Update Posted: | April 21, 2021 |
| Last Verified: | April 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Nantes University Hospital:
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sensitization pain thresholds |
Additional relevant MeSH terms:
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Pelvic Pain Pain Neurologic Manifestations |