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Neuropeptides and Venous Pelvic Pain (NVPP)

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ClinicalTrials.gov Identifier: NCT03921788
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sergey Gavrilov, Pirogov Russian National Research Medical University

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.

Condition or disease
Pelvic Pain Varicose Veins Pelvic Pelvic Congestion Syndrome

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.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Role of Vasoactive Neuropeptides in the Genesis of Venous Pelvic Pain
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

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)



Primary Outcome Measures :
  1. 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.

  2. 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


  3. 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




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women aged 18-45 years
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921788


Contacts
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Contact: Sergey G Gavrilov, MD 89169299947 gavriloffsg@mail.ru
Contact: Galina Yu Vassilieva, PhD 89169047087 galvassilieva@mail.ru

Locations
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Russian Federation
Department of Faculty Surgery №1 Recruiting
Moscow, Russian Federation, 119049
Contact: Galina G Vassilieva, PhD, PhD    89169047087    galvassilieva@mail.ru   
Contact: Anastasiya S Grishenkova    89162851112    ngrishenkova@rambler.ru   
Sponsors and Collaborators
Pirogov Russian National Research Medical University
Investigators
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Study Chair: Natalia V Koroleva, PhD Pirogov Russian National Research Medical University

Publications of Results:
Other Publications:
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Responsible Party: Sergey Gavrilov, Professor of the Department of Faculty Surgery №1, Pirogov Russian National Research Medical University
ClinicalTrials.gov Identifier: NCT03921788     History of Changes
Other Study ID Numbers: 01201254811
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sergey Gavrilov, Pirogov Russian National Research Medical University:
venous pelvic pain
pelvic congestion syndrome
calcitonin gene-related peptide
substance P

Additional relevant MeSH terms:
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Pelvic Pain
Varicose Veins
Pain
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Calcitonin
Katacalcin
Substance P
Neurokinin A
Calcitonin Gene-Related Peptide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents