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

NCT07163312 | Not Yet Recruiting

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

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Knee Pain Score (VAS)

  Visual Analog Scale (VAS, 0-10 cm)

  From baseline to 3 months after treatment

Secondary Outcomes (6)

• Change in Knee Function and Symptoms

  Baseline, 1 month, 3 months, and 6 months

• 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.

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 or Endovenous Laser Ablation), Endovenous Treatment for Varicose Veins, Standard Varicose Vein Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

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 (3)

• 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 BACKGROUND

• Zhang X, Joy DC. A simple specimen holder for EBIC imaging on the Hitachi S800. Microsc Res Tech. 1993 Oct 1;26(2):182-3. doi: 10.1002/jemt.1070260214. No abstract available.

  PMID: 8241555 BACKGROUND

• Reading AE, Everitt BS, Sledmere CM. The McGill Pain Questionnaire: a replication of its construction. Br J Clin Psychol. 1982 Nov;21 (Pt 4):339-49. doi: 10.1111/j.2044-8260.1982.tb00571.x.

  PMID: 7171883 BACKGROUND

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, Doctor

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: August 21, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share