Clinical trial NCT03921788: Neuropeptides and Venous Pelvic Pain
Official title: Study of the Role of Vasoactive Neuropeptides in the Genesis of Venous Pelvic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Pain
Varicose Veins Pelvic
Pelvic Congestion Syndrome
Keywords: venous pelvic pain
pelvic congestion syndrome
calcitonin gene-related peptide
substance P
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18-45 years

Brief summary: Mechanisms of the development of pain in chronic venous diseases (CVD), including pelvic congestion syndrome (PCS), are studied incompletely. The existing hypotheses of the occurrence of venous pelvic pain (VVP) do not allow to answer the question why some patients have no pain syndrome while others have very pronounced pain despite the same morphofunctional changes in the pelvic veins? The investigators are planning to carry out a study aimed at studying the content of calcitonin gene-related peptide (CGRP) and substance P (SP) in the serum of patients with pelvic veins and pelvic pain, and to study the relationship between the values of CGRP and SP in these patients.

Detailed description: The first phase of the study includes a set of 3 patient groups: the first is patients with pelvic vein dilation and blood reflux through them in combination with venous pelvic pain; the second is patients with pelvic vein dilatation without venous pelvic pain. The third, control group will include healthy female volunteers without pelvic veins and any chronic pain syndromes.

At the second stage of the study, a study will be made of the levels of calcitonin gene-related peptide (CGRP) and the substance P (SP) in the serum using an ELISA method. In addition, after studying the content of the CGRP and SP in the serum of volunteers, the investigators expect to obtain the reference values of these neuropeptides. In this phase of the study, a statistical analysis of the data obtained will be carried out, a correlation analysis between venous pelvic pain and the level of the CGRP and CP.

The data for each patient will be entered into a specially designed patient questionnaire. It will include clinical and ultrasound data, results of ELISA.

Eligibility criteria: Inclusion Criteria:

* The reproductive age of the woman
* Blood reflux in the parametric, uterine, gonadal veins
* The absence of any concomitant pathology, accompanied by chronic pelvic pain

Exclusion Criteria:

* The absence of blood reflux in in the parametric, uterine, gonadal veins
* The presence of diseases, the clinical course of which suggests the presence of chronic pelvic pain and other varieties of chronic pain, including migraine
* Pregnancy

Primary outcomes:
measure: The severity of venous pelvic pain
timeFrame: 5 min
measure: The level of calcitonin-gene-related peptide
timeFrame: 22 hours
measure: The level of substance P
timeFrame: 22 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Department of Faculty Surgery №1
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Natalia V Koroleva, PhD
role: STUDY_CHAIR
References:
citation: FitzGerald MP. Chronic pelvic pain. Curr Womens Health Rep. 2003 Aug;3(4):327-33.
citation: Stones RW, Thomas DC, Beard RW. Suprasensitivity to calcitonin gene-related peptide but not vasoactive intestinal peptide in women with chronic pelvic pain. Clin Auton Res. 1992 Oct;2(5):343-8. doi: 10.1007/BF01824305.
citation: Origoni M, Leone Roberti Maggiore U, Salvatore S, Candiani M. Neurobiological mechanisms of pelvic pain. Biomed Res Int. 2014;2014:903848. doi: 10.1155/2014/903848. Epub 2014 Jul 8.