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

NCT ID: NCT07239284

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2027-07-10

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Endovenous Ablation for Varicose Veins

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.

Intervention Type: PROCEDURE

Other Intervention Names

Endovenous Thermal Ablation; Radiofrequency Ablation; Endovenous Laser Ablation

Eligibility Criteria

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.

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chunshui He

Ph.D , Chief Physician of Vascular Surgery , Hospital of Chengdu University of Traditional Chinese Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chunshui He

Role: CONTACT

Chunshuihe@msn.com

18981885601

References

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.

Reference Type: RESULT

PMID: 37070890 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28631699 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34239634 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32318673 (View on PubMed)

Other Identifiers

chengduUTCM knee-80

Identifier Type: -

Identifier Source: org_study_id