Neuropeptides and Venous Pelvic Pain

Pelvic Pain Clinical Trial

— NVPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921788
• Other study ID #: 01201254811
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: February 11, 2022

Study information

• Verified date: October 2023
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 11, 2022
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Congestion Syndrome
• Pelvic Pain
• Varicose Veins
• Varicose Veins Pelvic

Locations

Country	Name	City	State
Russian Federation	Department of Faculty Surgery ?1	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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