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

NCT ID: NCT03541954

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2022-02-14

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.

Conditions

Chronic Pelvic Pain; Chronic Perineal Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Patient with pelvic or perineal pain with sensitization

Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5)

Group Type: OTHER

Sensory testing of lower urinary tract.

Intervention Type: OTHER

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

Sensory testing of lower rectal tract

Intervention Type: OTHER

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

Sensory testing of vulva muscles

Intervention Type: OTHER

Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.

Sensory testing of pelvic muscles

Intervention Type: OTHER

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

Patient with pelvic or perineal pain without sensitization

Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)

Group Type: OTHER

Sensory testing of lower urinary tract.

Intervention Type: OTHER

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

Sensory testing of lower rectal tract

Intervention Type: OTHER

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

Sensory testing of vulva muscles

Intervention Type: OTHER

Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.

Sensory testing of pelvic muscles

Intervention Type: OTHER

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

Interventions

Sensory testing of lower urinary tract.

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

Intervention Type: OTHER

Sensory testing of lower rectal tract

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

Intervention Type: OTHER

Sensory testing of vulva muscles

Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.

Intervention Type: OTHER

Sensory testing of pelvic muscles

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nantes university Hospital

Nantes, , France

Groupe Confluent

Nantes, , France

Countries

France

References

Cardaillac C, Levesque A, Riant T, Mortier A, Neunlist M, Perrouin-Verbe MA, Volteau C, Thubert T, Brochard C, Ploteau S. Evaluation of a scoring system for the detection of central sensitization among women with chronic pelvic pain. Am J Obstet Gynecol. 2023 Nov;229(5):530.e1-530.e17. doi: 10.1016/j.ajog.2023.07.044. Epub 2023 Jul 27.

Reference Type: DERIVED

PMID: 37516398 (View on PubMed)

Other Identifiers

RC17_0427

Identifier Type: -

Identifier Source: org_study_id