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

NCT ID: NCT07163312

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-11-01

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

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

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.

• Minimum Eligible Age: 18 Years
• Maximum 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, Doctor

Role: CONTACT

Chunshuihe@msn.com

18981885601

References

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: BACKGROUND

PMID: 28631699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8241555 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7171883 (View on PubMed)

Other Identifiers

chengduUTCM knee

Identifier Type: -

Identifier Source: org_study_id