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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age80+
SponsorChengdu University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

This study will enroll elderly patients aged 80 years or older who are diagnosed with primary lower extremity varicose veins and who also experience knee or peri-knee pain. Participants will be recruited from the outpatient vascular surgery clinics and inpatient wards of the participating hospital. All participants must be ambulatory and able to complete pain and function questionnaires. The study population represents older adults who are candidates for endovenous ablation under tumescent local anesthesia and who may benefit from venous reflux correction.

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
Baseline, 1 month, 3 months, and 6 months
2

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

1

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.
2

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.
3

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
4

Use of Analgesic Medications

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

Time frame
6 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: