Neuropeptides and Venous Pelvic Pain (NVPP)

Study of the Role of Vasoactive Neuropeptides in the Genesis of 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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119049
    • Department of Faculty Surgery №1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18-45 years

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 1; Patients with venous pelvic pain. Pain measurement using a visual analogue scale, the study of calcitonin gene-related peptide and substance P (ELISA)
Group 2; Patients without venous pelvic pain. Pain measurement using a visual analogue scale, the study of calcitonin gene-related peptide and substance P (ELISA)
Group 3; Volunteers without pain syndromes of any location. Pain measurement using a visual analogue scale, the study of calcitonin gene-related peptide and substance P (ELISA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of venous pelvic pain	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.	5 min
The level of calcitonin-gene-related peptide	Protocol V (Ab1hr.Std2hr. BtON) was used for the enzyme-linked immunosorbent assay (ELISA). The indicator is measured in ng / ml	22 hours
The level of substance P	Protocol V (Ab1hr.Std2hr. BtON) was used for the enzyme-linked immunosorbent assay (ELISA). The indicator is measured in ng / ml	22 hours

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Investigators: Study Chair: Natalia V Koroleva, PhD, Pirogov Russian National Research Medical University

Publications and helpful links

General Publications

• 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.
• FitzGerald MP. Chronic pelvic pain. Curr Womens Health Rep. 2003 Aug;3(4):327-33.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 12, 2021
• Study Completion (Actual): February 11, 2022

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: substance P; calcitonin gene-related peptide; pelvic congestion syndrome; venous pelvic pain
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Varicose Veins; Pelvic Pain
• Other Study ID Numbers: 01201254811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No