Knee Pain Relief After Endovenous Treatment for Lower Limb Varicose Veins: A Prospective Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endovenous Ablation for Varicose Veins.
- Who it may be relevant to
- Registry conditions: Varicose Veins of Lower Limb, Chronic Venous Insufficiency, CVI, Knee Pain Chronic, Knee Osteoarthritis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Observational Cohort Study of Knee Pain and Function After Endovenous Treatment for Lower Limb Varicose Veins
Overview
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.
Interventions
- Procedure 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
Primary outcome measures
- Change in Knee Pain Score (VAS) [Time frame: From baseline to 3 months after treatment]
Secondary outcome measures (6)
- Change in Knee Function and Symptoms [Time frame: Baseline, 1 month, 3 months, and 6 months]
- Change in Venous Clinical Severity Score (VCSS) [Time frame: Baseline, 1 month, 3 months, and 6 months.]
- Change in Aberdeen Varicose Vein Questionnaire (AVVQ) [Time frame: Baseline, 1 month, 3 months, and 6 months.]
- Change in Health-Related Quality of Life [Time frame: Baseline, 1 month, 3 months, and 6 months]
- Use of Analgesic Medications [Time frame: 6 months.]
- Adverse Events Related to Procedure [Time frame: Within 6 months after procedure.]
Eligibility criteria
Inclusion criteria
Adults aged ≥18 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07163312 · chengduUTCM knee