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

NCT07239284 | Not Yet Recruiting

• 1 other identifier: chengduUTCM knee-80
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Varicose Veins of Lower Limb; Chronic Venous Insufficiency, CVI; Knee Pain; Knee Osteoarthritis; Elderly Patients

Outcome Measures

Primary Outcomes (2)

• Change in Knee Pain Score (VAS)

  Visual Analog Scale (VAS, 0-10 cm)

  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.

  Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (5)

• Change in Venous Clinical Severity Score (VCSS)

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

• Change in Aberdeen Varicose Vein Questionnaire (AVVQ)

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

• Change in Health-Related Quality of Life

  Baseline, 1 month, 3 months, and 6 months

• Use of Analgesic Medications

  6 months.

• Adverse Events Related to Procedure

  Within 6 months after procedure.

Interventions

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.

Also known as: Endovenous Thermal Ablation, Radiofrequency Ablation, Endovenous Laser Ablation

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Related Publications (4)

• Cao TN, Nguyen CT, Nguyen MD. The association between chronic venous disease and knee osteoarthritis. Eur Rev Med Pharmacol Sci. 2023 Apr;27(7):2899-2907. doi: 10.26355/eurrev_202304_31921.

  PMID: 37070890 RESULT

• Lesnyak OM, Zubareva EV, Goncharova MG, Maksimov DM. [Lower extremity venous diseases in primary knee osteoarthritis]. Ter Arkh. 2017;89(5):53-59. doi: 10.17116/terarkh201789553-59. Russian.

  PMID: 28631699 RESULT

• Oga Y, Sugiyama S, Matsubara S, Inaki Y, Matsunaga M, Shindo A. The Effectiveness of Endovenous Thermal Ablation for the Knee Symptoms of the Osteoarthritis with Varicose Veins. Ann Vasc Dis. 2021 Jun 25;14(2):108-111. doi: 10.3400/avd.oa.21-00016.

  PMID: 34239634 RESULT

• Gunes S, Sehim K, Cuneyt K, Gokmen D, Kucukdeveci AA. Is there a relationship between venous insufficiency and knee osteoarthritis? Turk J Phys Med Rehabil. 2020 Mar 3;66(1):40-46. doi: 10.5606/tftrd.2020.5110. eCollection 2020 Mar.

  PMID: 32318673 RESULT

MeSH Terms

Conditions

Blindness, Cortical; Osteoarthritis, Knee

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Chunshui He

CONTACT

18981885601; Chunshuihe@msn.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D , Chief Physician of Vascular Surgery , Hospital of Chengdu University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): July 10, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share