An observational study in Pelvic Pain, Varicose Veins Pelvic and Pelvic Congestion Syndrome, sponsored by Pirogov Russian National Research Medical University. Completed at 1 site in Russia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Pirogov Russian National Research Medical University · Observational
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.
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.
376 studies on the registry are indexed under Pelvic Pain; 90 are open to participants now.
This study's enrollment of 120 is above the median of 100 across 83 observational studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Pirogov Russian National Research Medical University is the lead sponsor of 57 studies on the registry; 15 are open to participants now.
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Women aged 18-45 years
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Exclusion Criteria:
Patients with venous pelvic pain. Pain measurement using a visual analogue scale, the study of calcitonin gene-related peptide and substance P (ELISA)
Patients without venous pelvic pain. Pain measurement using a visual analogue scale, the study of calcitonin gene-related peptide and substance P (ELISA)
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)
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.
Time frame: 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
Time frame: 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
Time frame: 22 hours
Plan to share: No
Ran from Apr 2019 to primary completion in Dec 2021, 32 months.
Of 33 observational studies under Pelvic Pain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15. This study's 32 months is close to that.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Pirogov Russian National Research Medical University