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NCT03921788·Not applicable·OBSERVATIONAL

Neuropeptides and Venous Pelvic Pain

CalcitoninPainCompleted

Status

Completed

Phase

Not applicable

Enrollment

120

Locations

1

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Apr 19, 2019

  2. Study start

    Apr 1, 2019

  3. Primary completion

    Dec 12, 2021

  4. Study completion

    Feb 11, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Oct 23, 2023

Outcomes

What the study measures.

Primary outcomes

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.

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

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
FEMALE
Healthy volunteers
Yes

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 locations

1 registered sites.

Russia. Showing up to 24 locations stored in the fast local snapshot.

Department of Faculty Surgery №1

Moscow, Russia

Publications

Results and literature.

PMID 12844458 ↗FitzGerald MP. Chronic pelvic pain. Curr Womens Health Rep. 2003 Aug;3(4):327-33.PMID 1422102 ↗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 25110704 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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