Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population (DOPEC)
Primary Purpose
Chronic Pelvic Pain, Chronic Perineal Pain
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sensory testing of lower urinary tract.
Sensory testing of lower rectal tract
Sensory testing of vulva muscles
Sensory testing of pelvic muscles
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Pelvic Pain focused on measuring sensitization, pain thresholds
Eligibility 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).
Sites / Locations
- Nantes university Hospital
- Groupe Confluent
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patient with pelvic or perineal pain with sensitization
Patient with pelvic or perineal pain without sensitization
Arm Description
Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5)
Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria < 5)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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).
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).
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).
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).
Full Information
NCT ID
NCT03541954
First Posted
May 17, 2018
Last Updated
March 24, 2022
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03541954
Brief Title
Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population
Acronym
DOPEC
Official Title
Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population : a Prospective Controlled Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
End of inclusions
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
February 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain, Chronic Perineal Pain
Keywords
sensitization, pain thresholds
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with pelvic or perineal pain with sensitization
Arm Type
Other
Arm Description
Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5)
Arm Title
Patient with pelvic or perineal pain without sensitization
Arm Type
Other
Arm Description
Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria < 5)
Intervention Type
Other
Intervention Name(s)
Sensory testing of lower urinary tract.
Intervention Description
Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds.
Intervention Type
Other
Intervention Name(s)
Sensory testing of lower rectal tract
Intervention Description
Lower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension).
Intervention Type
Other
Intervention Name(s)
Sensory testing of vulva muscles
Intervention Description
Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.
Intervention Type
Other
Intervention Name(s)
Sensory testing of pelvic muscles
Intervention Description
Myofascial sensitivity testing: piriformis, levator ani and obturator internus muscles pressure pain threshold evaluated using intra-vaginal algometer.
Primary Outcome Measure Information:
Title
Comparison of pelvic pain threshold
Description
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).
Time Frame
1 month after inclusion in the study
Secondary Outcome Measure Information:
Title
Identification of temporal distribution of pain
Description
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).
Time Frame
1 month after inclusion in the study
Title
Identification of lower pain perception thresholds
Description
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.
Time Frame
1 month after inclusion in the study
Title
Comparison of state anxiety
Description
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).
Time Frame
1 month after inclusion in the study
Title
Comparison of depression
Description
Comparison of depression between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5).
Time Frame
1 month after inclusion in the study
Title
Comparison of catastrophizing
Description
Comparison of catastrophizing between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5).
Time Frame
1 month after inclusion in the study
Title
Comparison of quality of life
Description
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).
Time Frame
1 month after inclusion in the study
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Nantes university Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Groupe Confluent
City
Nantes
ZIP/Postal Code
44277
Country
France
12. IPD Sharing Statement
Learn more about this trial
Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population
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