Prospective Observational Cohort Study of Knee Pain and Function After Endovenous Treatment for Lower Limb Varicose Veins
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Change in Knee Pain Score (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Knee Pain Score (VAS)
时间窗: From baseline to 3 months after treatment
Visual Analog Scale (VAS, 0-10 cm)
次要结局
- Change in Venous Clinical Severity Score (VCSS)(Baseline, 1 month, 3 months, and 6 months.)
- Change in Knee Function and Symptoms(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.)
研究者
Chunshui He
Ph.D , Chief Physician of Vascular Surgery , Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine