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Neuropeptides and Venous Pelvic Pain (NVPP)
| Condition or disease |
|---|
| Pelvic Pain Varicose Veins Pelvic Pelvic Congestion Syndrome |
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.
| 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 : | October 2022 |
| Estimated Study Completion Date : | April 2023 |
| 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)
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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)
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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)
|
- 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
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
| Contact: Sergey G Gavrilov, MD | 89169299947 | gavriloffsg@mail.ru | |
| Contact: Galina Yu Vassilieva, PhD | 89169047087 | galvassilieva@mail.ru |
| 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 | |
| Study Chair: | Natalia V Koroleva, PhD | Pirogov Russian National Research Medical University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 12, 2019 | ||||||||
| First Posted Date | April 19, 2019 | ||||||||
| Last Update Posted Date | September 16, 2020 | ||||||||
| Actual Study Start Date | April 1, 2019 | ||||||||
| Estimated Primary Completion Date | October 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Neuropeptides and Venous Pelvic Pain | ||||||||
| Official Title | Study of the Role of Vasoactive Neuropeptides in the Genesis of Venous Pelvic Pain | ||||||||
| 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. | ||||||||
| 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 | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Women aged 18-45 years | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
120 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | April 2023 | ||||||||
| Estimated Primary Completion Date | October 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 45 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | Russian Federation | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03921788 | ||||||||
| Other Study ID Numbers | 01201254811 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Sergey Gavrilov, MD, PhD, Pirogov Russian National Research Medical University | ||||||||
| Study Sponsor | Pirogov Russian National Research Medical University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Pirogov Russian National Research Medical University | ||||||||
| Verification Date | April 2020 | ||||||||
