Neuropeptides and Venous Pelvic Pain

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.

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Key information

Conditions

Pelvic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Congestion Syndrome Signs and Symptoms Varicose Veins Pelvic

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Faculty Surgery №1

Moscow, 119049, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The severity of venous pelvic pain

Time frame: 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

Time frame: 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

Time frame: 22 hours

Protocol V (Ab1hr.Std2hr. BtON) was used for the enzyme-linked immunosorbent assay (ELISA).

The indicator is measured in ng / ml

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Official study title

Study of the Role of Vasoactive Neuropeptides in the Genesis of Venous Pelvic Pain

Acronym: NVPP

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2022
First posted: Apr 19, 2019
Registry last updated: Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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