Neuropeptides and Venous Pelvic Pain

NCT03921788 | Completed

• 1 other identifier: 01201254811
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Varicose Veins Pelvic; Pelvic Congestion Syndrome

Keywords

venous pelvic pain; pelvic congestion syndrome; calcitonin gene-related peptide; substance P

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18-45 years

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Department of Faculty Surgery №1

Moscow, 119049, Russia

Location

Related Publications (3)

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

  PMID: 12844458 BACKGROUND

• 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.

  PMID: 1422102 RESULT

• 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.

  PMID: 25110704 RESULT

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Natalia V Koroleva, PhD

  Pirogov Russian National Research Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Department of Faculty Surgery №1

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 19, 2019
• Study Start: April 1, 2019
• Primary Completion: December 12, 2021
• Study Completion: February 11, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)