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

N/ANot Yet RecruitingNCT07163312

Chengdu University of Traditional Chinese Medicine50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Endovenous Ablation for Varicose VeinsPROCEDURE

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 investigational devices are used.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: 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.

Outcomes

Primary Outcomes

Change in Knee Pain Score (VAS)

Visual Analog Scale (VAS, 0-10 cm)

Time frame: From baseline to 3 months after treatment

Secondary Outcomes

Change in Knee Function and Symptoms

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) evaluates knee-related pain, stiffness, and functional limitations.Scoring Range: 0 to 96, with higher scores indicating worse symptoms and greater functional impairment.

Time frame: Baseline, 1 month, 3 months, and 6 months

Change in Venous Clinical Severity Score (VCSS)

The Venous Clinical Severity Score (VCSS) assesses the severity of chronic venous disease and varicose vein-related symptoms.Scoring Range: 0 to 30, with higher scores indicating more severe venous disease.

Time frame: Baseline, 1 month, 3 months, and 6 months.

Change in Aberdeen Varicose Vein Questionnaire (AVVQ)

The Aberdeen Varicose Vein Questionnaire (AVVQ) measures varicose vein-specific quality of life.Scoring Range: 0 to 100, with higher scores indicating worse quality of life.

Time frame: Baseline, 1 month, 3 months, and 6 months.

Change in Health-Related Quality of Life

The Chronic Venous Insufficiency Questionnaire (CIVIQ-14) is a 14-item disease-specific instrument used to assess quality of life in patients with chronic venous disease. It covers domains of pain, physical function, and psychological impact. Scoring Range: 0 to 100, with higher scores indicating worse quality of life.

Time frame: Baseline, 1 month, 3 months, and 6 months

Use of Analgesic Medications

Number of patients using NSAIDs or other pain medications for knee pain.

Time frame: 6 months.

Adverse Events Related to Procedure

Number and type of adverse events (nerve injury, phlebitis, DVT, infection).

Time frame: Within 6 months after procedure.