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

NCT03541954 | Terminated

• 1 other identifier: RC17_0427
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pelvic Pain; Chronic Perineal Pain

Keywords

sensitization; pain thresholds

Outcome Measures

Primary Outcomes (1)

• 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).

  1 month after inclusion in the study

Secondary Outcomes (6)

• Identification of temporal distribution of pain

  1 month after inclusion in the study

• Identification of lower pain perception thresholds

  1 month after inclusion in the study

• Comparison of state anxiety

  1 month after inclusion in the study

• Comparison of depression

  1 month after inclusion in the study

• Comparison of catastrophizing

  1 month after inclusion in the study

Study Arms (2)

Patient with pelvic or perineal pain with sensitization

OTHER

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

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

Patient with pelvic or perineal pain without sensitization

OTHER

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

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

Interventions

Sensory testing of lower urinary tract. OTHER

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

Patient with pelvic or perineal pain with sensitization; Patient with pelvic or perineal pain without sensitization

Sensory testing of lower rectal tract OTHER

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

Patient with pelvic or perineal pain with sensitization; Patient with pelvic or perineal pain without sensitization

Sensory testing of vulva muscles OTHER

Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.

Patient with pelvic or perineal pain with sensitization; Patient with pelvic or perineal pain without sensitization

Sensory testing of pelvic muscles 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 with sensitization; Patient with pelvic or perineal pain without sensitization

Eligibility Criteria

• Age: 25 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

Nantes university Hospital

Nantes, 44093, France

Location

Groupe Confluent

Nantes, 44277, France

Location

Related Publications (1)

• 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.

  PMID: 37516398 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 31, 2018
• Study Start: July 17, 2018
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

FR (2)