Varicose Veins of Lower LimbVV-KNEENCT07163312
Knee Pain Relief After Endovenous Treatment for Lower Limb Varicose Veins: A Prospective Observational Study
An observational study of Varicose Veins of Lower Limb and Chronic Venous Insufficiency, CVI, run by Chengdu University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins of Lower Limb, Chronic Venous Insufficiency, CVI, Knee Pain Chronic
- What is being tested?
- Endovenous Ablation for Varicose Veins
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Nov 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Observational Cohort Study of Knee Pain and Function After Endovenous Treatment for Lower Limb Varicose Veins
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
- Being tested
- Endovenous Ablation for Varicose Veins
- Medical subject headings
- Blindness, Cortical, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous Ablation for Varicose VeinsProcedure or surgery
Also called Endovenous Thermal Ablation (Radiofrequency Ablation or Endovenous Laser Ablation), Endovenous Treatment for Varicose Veins, Standard Varicose Vein Surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Pain Score (VAS)
Visual Analog Scale (VAS, 0-10 cm)
Measured: From baseline to 3 months after treatment
Secondary outcomes (6)
Change in Knee Function and Symptoms
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) evaluates knee-related pain, stiffness, and functional limitations.Scoring Range: 0 to 96, with higher scores indicating worse symptoms and greater functional impairment.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Venous Clinical Severity Score (VCSS)
The Venous Clinical Severity Score (VCSS) assesses the severity of chronic venous disease and varicose vein-related symptoms.Scoring Range: 0 to 30, with higher scores indicating more severe venous disease.
Measured: Baseline, 1 month, 3 months, and 6 months.
Change in Aberdeen Varicose Vein Questionnaire (AVVQ)
The Aberdeen Varicose Vein Questionnaire (AVVQ) measures varicose vein-specific quality of life.Scoring Range: 0 to 100, with higher scores indicating worse quality of life.
Measured: Baseline, 1 month, 3 months, and 6 months.
Change in Health-Related Quality of Life
The Chronic Venous Insufficiency Questionnaire (CIVIQ-14) is a 14-item disease-specific instrument used to assess quality of life in patients with chronic venous disease. It covers domains of pain, physical function, and psychological impact. Scoring Range: 0 to 100, with higher scores indicating worse quality of life.
Measured: Baseline, 1 month, 3 months, and 6 months
Use of Analgesic Medications
Number of patients using NSAIDs or other pain medications for knee pain.
Measured: 6 months.
Adverse Events Related to Procedure
Number and type of adverse events (nerve injury, phlebitis, DVT, infection).
Measured: Within 6 months after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunshui He, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163312
- Sponsor's protocol ID
- chengduUTCM knee
- Acronym
- VV-KNEE
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan Description: Individual participant data (IPD) will not be shared because the study is observational, single-center, and involves limited sample size. Data will be used only for the purpose of this research project and protected according to institutional regulations.
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.
PubMed 28631699Oga 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.
PubMed 34239634Gunes 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.
PubMed 32318673
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study of Knee Pain and Function After Endovenous Treatment for Lower Limb Varicose Veins
- ClinicalTrials.gov ID
- NCT07163312
- Acronym / sponsor ID
- VV-KNEE / chengduUTCM knee
- Conditions
- Varicose Veins of Lower Limb, Chronic Venous Insufficiency, CVI, Knee Pain Chronic, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovenous Ablation for Varicose VeinsAlso: Endovenous Thermal Ablation (Radiofrequency Ablation or Endovenous Laser Ablation), Endovenous Treatment for Varicose Veins, Standard Varicose Vein SurgeryParticipants 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. | Procedure or surgery | – |
Primary outcome
Change in Knee Pain Score (VAS)
Time frame: From baseline to 3 months after treatment
Visual Analog Scale (VAS, 0-10 cm)
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 28631699Lesnyak 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.
- Results publication: PubMed 34239634Oga 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.
- Results publication: PubMed 32318673Gunes 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.
- Individual participant dataSharing planned: No. Plan Description: Individual participant data (IPD) will not be shared because the study is observational, single-center, and involves limited sample size. Data will be used only for the purpose of this research project and protected according to institutional regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins of Lower Limb and Chronic Venous Insufficiency, CVI, run by Chengdu University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunshui He, Doctor (18981885601, Chunshuihe@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Pain Score (VAS) (time frame: From baseline to 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163312, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.