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NCT Number: NCT07163312

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

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.

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Key information

Conditions

Varicose Veins of Lower Limb Arthritis Blindness Blindness, Cortical Chronic Venous Insufficiency, CVI Eye Diseases Joint Diseases Knee Osteoarthritis Knee Pain Chronic Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endovenous Ablation for Varicose Veins

Procedure

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.

Other names: Endovenous Thermal Ablation (Radiofrequency Ablation or Endovenous Laser Ablation), Endovenous Treatment for Varicose Veins, Standard Varicose Vein Surgery

Primary outcomes

  1. Change in Knee Pain Score (VAS)

    Time frame: From baseline to 3 months after treatment

    Visual Analog Scale (VAS, 0-10 cm)

Secondary outcomes

  1. Change in Knee Function and Symptoms

    Time frame: 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.

  2. Change in Venous Clinical Severity Score (VCSS)

    Time frame: 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.

  3. Change in Aberdeen Varicose Vein Questionnaire (AVVQ)

    Time frame: 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.

  4. Change in Health-Related Quality of Life

    Time frame: 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.

  5. Use of Analgesic Medications

    Time frame: 6 months.

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

  6. Adverse Events Related to Procedure

    Time frame: Within 6 months after procedure.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chunshui He, Doctor

CONTACT

[email protected]

18981885601

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Acronym: VV-KNEE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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