Neuropeptides and Venous Pelvic Pain

Completed

• Conditions: Varicose Veins Pelvic; Pelvic Pain; Pelvic Congestion Syndrome

• Registration Number: NCT03921788
• Lead Sponsor: Pirogov Russian National Research Medical University

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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Primary Completion: 2021-12-12
• Study Completion: 2022-02-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of venous pelvic pain	5 min	For the quantitative determination of the severity of venous pelvic pain using a visual analogue scale, measurement in points. The visual analogue scale (VAS) consists of a straight line with the endpoints defining extreme limits such as "no pain at all" and "pain as bad as it could be". The patient is asked to mark his pain level on the line between the two endpoints. The distance between "no pain at all" and the mark then defines the subject's pain.
The level of calcitonin-gene-related peptide	22 hours	Protocol V (Ab1hr.Std2hr. BtON) was used for the enzyme-linked immunosorbent assay (ELISA).; The indicator is measured in ng / ml
The level of substance P	22 hours	Protocol V (Ab1hr.Std2hr. BtON) was used for the enzyme-linked immunosorbent assay (ELISA).; The indicator is measured in ng / ml

Trial Locations

Locations (1)

Department of Faculty Surgery №1; 🇷🇺 Moscow, Russian Federation