Efficacy and Safety of Endovenous Ablation for Relief of Knee Pain in Elderly Patients With Lower Extremity Varicose Veins: A Prospective Observational Study

N/ANot Yet RecruitingNCT07239284

Chengdu University of Traditional Chinese Medicine50 enrolled

Overview

Lower extremity varicose veins (LEVV) are common among elderly patients and can cause leg heaviness, pain, and swelling. In some older adults, venous congestion may contribute to knee or peri-knee pain, which is often misattributed to degenerative joint disease alone. Evidence on whether varicose vein treatment can relieve knee pain in very elderly patients (aged 80 years or older) is limited. This prospective cohort study aims to evaluate the effectiveness and safety of endovenous ablation (EVA) for improving knee pain in elderly patients with symptomatic varicose veins. The study will include participants aged 80 years or older who present with both lower extremity varicose veins and knee joint pain. Eligible patients will undergo endovenous thermal ablation (radiofrequency or endovenous laser ablation) as the primary intervention. Participants will be assessed at baseline, 1 month, 3 months, 6 months, and 12 months after treatment. The primary outcome is the change in knee pain intensity measured by the Visual Analog Scale (VAS) from baseline to 6 months. Secondary outcomes include changes in knee joint function (assessed by the Western Ontario and McMaster Universities Osteoarthritis Index \[WOMAC\] or Knee Injury and Osteoarthritis Outcome Score \[KOOS\]), venous clinical severity score (VCSS), limb heaviness, quality of life (assessed by EQ-5D), and procedure-related complications. Safety will be evaluated by recording peri-procedural adverse events, including deep vein thrombosis, skin burns, nerve injury, and postoperative infection. The study will also analyze whether preexisting osteoarthritis, venous reflux severity, or body mass index (BMI) affect the magnitude of pain improvement. The hypothesis is that endovenous ablation improves knee pain in elderly patients by reducing venous congestion around the knee and improving venous return. This study will help clarify whether treating varicose veins can provide additional benefits for knee pain and mobility in patients aged 80 years and older.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Varicose Veins of Lower Limb

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: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Adults aged ≥80 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: Baseline, 1 month, 3 months, and 6 months

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

Secondary Outcomes

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.

Efficacy and Safety of Endovenous Ablation for Relief of Knee Pain in Elderly Patients With Lower Extremity Varicose Veins: A Prospective Observational Study

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts