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Набор скоро начнётся NCT07163312

Knee Pain Relief After Endovenous Treatment for Lower Limb Varicose Veins: A Prospective Observational Study

— Наблюдательное Varicose Veins of Lower Limb Chronic Venous Insufficiency, CVI Knee Pain Chronic Knee Osteoarthritis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Endovenous Ablation for Varicose Veins.
Кому может быть актуально
Состояния в реестре: Varicose Veins of Lower Limb, Chronic Venous Insufficiency, CVI, Knee Pain Chronic, Knee Osteoarthritis. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Observational Cohort Study of Knee Pain and Function After Endovenous Treatment for Lower Limb Varicose Veins

Обзор

This study will observe patients with lower limb varicose veins who also have knee pain. Many patients with varicose veins experience swelling, heaviness, or aching in the legs, and some also report pain in or around the knee. Previous studies suggest that venous reflux and poor circulation may increase discomfort in the knee, especially when knee osteoarthritis is present. The purpose of this study is to evaluate whether treatment of varicose veins with standard endovenous procedures can improve knee pain and function. Participants will undergo standard vein treatment as part of their clinical care. We will follow them for changes in knee pain, quality of life, and leg symptoms over time. This study does not assign patients to experimental interventions. Instead, it collects information before and after treatment to better understand the relationship between varicose veins and knee pain relief. Findings from this study may help doctors identify which patients are most likely to benefit from venous treatment in terms of both leg and knee symptoms.

Вмешательства

  • Процедура Endovenous Ablation for Varicose Veins
    Participants will receive standard endovenous treatment for lower limb varicose veins as part of their routine clinical care. The procedure may include radiofrequency ablation (RFA), endovenous laser ablation (EVLA), or other accepted thermal ablation techniques, with or without adjunctive phlebectomy or foam sclerotherapy if clinically indicated. The intervention is performed under tumescent local anesthesia by vascular surgeons according to established guidelines. No experimental techniques or

Первичные конечные точки

  • Change in Knee Pain Score (VAS) [Срок оценки: From baseline to 3 months after treatment]
Вторичные конечные точки (6)
  • Change in Knee Function and Symptoms [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
  • Change in Venous Clinical Severity Score (VCSS) [Срок оценки: Baseline, 1 month, 3 months, and 6 months.]
  • Change in Aberdeen Varicose Vein Questionnaire (AVVQ) [Срок оценки: Baseline, 1 month, 3 months, and 6 months.]
  • Change in Health-Related Quality of Life [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
  • Use of Analgesic Medications [Срок оценки: 6 months.]
  • Adverse Events Related to Procedure [Срок оценки: Within 6 months after procedure.]

Критерии участия

Критерии включения

Adults aged ≥18 years. Clinical diagnosis of lower limb varicose veins with documented venous reflux on duplex ultrasound (CEAP C2-C4).

Presence of knee pain lasting ≥4 weeks prior to enrollment, confirmed by patient-reported VAS/NRS ≥3 at baseline.

Planned to undergo standard endovenous treatment (radiofrequency ablation, endovenous laser ablation, or equivalent).

Ability to provide informed consent and complete study questionnaires.

Критерии исключения

Prior surgery or endovenous ablation for varicose veins in the same limb. History of inflammatory arthritis (e.g., rheumatoid arthritis, gout) or other systemic rheumatologic disease.

Recent acute knee injury (ligament, meniscus, fracture) within 6 months. Prior knee replacement or major knee surgery. Recent intra-articular injection or arthroscopy (<3 months). Known deep vein thrombosis or history of pulmonary embolism within the past 6 months.

Severe peripheral arterial disease (ABI <0.8). Pregnancy or breastfeeding. Inability to comply with follow-up schedule or complete questionnaires.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Lesnyak OM, Zubareva EV, Goncharova MG, Maksimov DM. [Lower extremity venous diseases in primary knee osteoarthritis]. Ter Arkh. 2017;89(5):53-59. doi: 10.17116/terarkh201789553-59. Russian. PMID 28631699
  • Oga Y, Sugiyama S, Matsubara S, Inaki Y, Matsunaga M, Shindo A. The Effectiveness of Endovenous Thermal Ablation for the Knee Symptoms of the Osteoarthritis with Varicose Veins. Ann Vasc Dis. 2021 Jun 25;14(2):108-111. doi: 10.3400/avd.oa.21-00016. PMID 34239634
  • Gunes S, Sehim K, Cuneyt K, Gokmen D, Kucukdeveci AA. Is there a relationship between venous insufficiency and knee osteoarthritis? Turk J Phys Med Rehabil. 2020 Mar 3;66(1):40-46. doi: 10.5606/tftrd.2020.5110. eCollection 2020 Mar. PMID 32318673

Идентификаторы

NCT: NCT07163312 · chengduUTCM knee

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗