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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03921788
Other study ID # 01201254811
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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