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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorChengdu University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

This study will include adult patients with clinically significant lower limb varicose veins (CEAP C2-C4) who also report knee pain. Participants are recruited from vascular surgery outpatient clinics and will undergo standard endovenous treatment as part of their clinical care. The study will observe changes in knee pain, function, and venous symptoms before and after treatment. Patients with advanced joint disease, systemic inflammatory disorders, or recent knee surgery are excluded to minimize confounding factors.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endovenous Ablation for Varicose Veins

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Change in Knee Pain Score (VAS)

Visual Analog Scale (VAS, 0-10 cm)

Time frame
From baseline to 3 months after treatment

Secondary outcomes

1

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
2

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.
3

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.
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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