Chronic Venous Insufficiency, CVI, Knee Osteoarthritis, Knee Pain Chronic, Varicose Veins of Lower Limb
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Pain Score (VAS) | From baseline to 3 months after treatment | Visual Analog Scale (VAS, 0-10 cm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Venous Clinical Severity Score (VCSS) | Baseline, 1 month, 3 months, and 6 months. | 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. |
| Change in Aberdeen Varicose Vein Questionnaire (AVVQ) | Baseline, 1 month, 3 months, and 6 months. | 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. |
| Change in Knee Function and Symptoms | Baseline, 1 month, 3 months, and 6 months | 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. |
| Use of Analgesic Medications | 6 months. | Number of patients using NSAIDs or other pain medications for knee pain. |
| Adverse Events Related to Procedure | Within 6 months after procedure. | Number and type of adverse events (nerve injury, phlebitis, DVT, infection). |
| Change in Health-Related Quality of Life | Baseline, 1 month, 3 months, and 6 months | 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. |
Contacts
Primary ContactChunshui He, Doctor
Outcome results
None listed