UMIN-CTR Clinical Trial

Public title

Evaluation of the Impact of Varicose Veins on Knee Osteoarthritis

Acronym

Evaluation of the Impact of Varicose Veins on Knee Osteoarthritis

Scientific Title

Evaluation of the Effect of Varicose Veins on Knee Osteoarthritis

Scientific Title:Acronym

Evaluation of the Effect of Varicose Veins on Knee Osteoarthritis

Region

Japan

Condition

Knee Osteoarthritis, Varicose Veins, knee pain

Classification by specialty

Vascular surgery

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aimed to verify that
1. The prevalence of varicose veins of the lower extremities among patients with knee osteoarthritis is higher than that reported in normal population.
2. Symptoms of knee osteoarthritis can be improved by varicose veins treatment with compression stockings.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Improvement of knee pain or some symptoms in lower extremities such as edema. Medical interview with original classifications are administered at baseline, within 2 month after intervention , 4-12 months and more after intervention.

Key secondary outcomes

Knee pain : NRS (Numerical Rating Scale) of knee pain, KOOS (Knee injury, Osteoarthritis Outcome Score) Medical interview are administered at baseline, 1-2, 3, and 6 months and more after treatment.
Presence of varicose veins ( before intervention) : Varicose veins are diagnosed by detecting the reverse flow of venous blood over 0.5 s using duplex scanning by ultrasonography of the lower extremities

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

1. No intervention : only detection by ultrasonography of the lower extremities.
2. All included patients (with or without varicose veins) are treated with compression stockings for varicose vein treatments, until requesting termination of treatment with the stocking.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Inclusion Criteria
1 Attendance at orthopedic outpatient clinic in this institution
2 Presence of knee pain
3 Diagnosis of knee osteoarthritis diagnosed by Kellgren Lawrence classification 1 or more
4 Ability to walk independently such as either unaided or with the use of a cane
5 Consent to the explanation of the purpose and content of this study

Key exclusion criteria

Exclusion Criteria
1 Presence of collagen disease or rheumatoid arthritis
2 Acute pain due to osteonecrosis of knee
3 Temporary exacerbation of pain due to trauma around knee or injury of ligament, tendon or meniscus
4 Decreased walking ability during this study
5 Preference for surgical treatment
6 Presence of dementia
7 Cases in which knee pain has improved before intervention.

Target sample size

100

Name of lead principal investigator

1st name	Yasuzumi
Middle name
Last name	Kishimoto

Organization

Tohno Kousei Hospital

Division name

Department of Orthopedic Surgery

Zip code

509-6101

Address

76-1 Tokicho, Mizunami City, Gifu Prefecture

TEL

0572-68-4111

Email

ksmt1023@gmail.com

Name of contact person

1st name	Yasuzumi
Middle name
Last name	Kishimoto

Organization

Tohno Kousei Hospital

Division name

Department of Orthopedic Surgery

Zip code

509-6101

Address

76-1 Tokicho, Mizunami City, Gifu Prefecture

TEL

0572-68-4111

Homepage URL

Email

ksmt1023@gmail.com

Institute

Tohno Kousei Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tohno Kousei Hospital

Address

76-1 Tokicho, Mizunami City, Gifu Prefecture

Tel

0572-68-4111

Email

ksmt1023@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

https://www.ors.org/abstract-search/ https://apps.m-anage.com/eors2024/en-GB/pag/

Number of participants that the trial has enrolled

100

Results

I gave conference presentations about progress report of this study
1. The Orthopaedic Research Society (ORS) : Long beach : February 2024
2. The European Orthopaedic Research Society (EORS) Denmark : September 2024

Results
The prevalence of varicose vein (VV) is 67.0% (65/97)


Effect of stockings for VV treatment on knee pain

VV groups (n=47)
Improvement in knee pain: 31
No improvement in knee pain: 16

No VV groups (n=18)
Improvement in knee pain: 1
No improvement in knee pain: 17

Results date posted

2025

Year

01

Month

22

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

A total of 100 participants
98 Japanese, 1 Afghanistan, 1 Brazilian
All participants were female and were capable of independent ambulation (either walking unaided or using a cane).
Of the 100 participants, 3 Japanese individuals were diagnosed with deep vein thrombosis (DVT) and were excluded from the prevalence survey, leaving 97 participants for analysis.
The age distribution among these 97 participants: 50 to 59 years :8 60 to 69 years :21 70 to 79 years: 41 80 to 89 years: 25 90 to 99 years: 2 Mean height 151 cm Mean weight 55 kg Mean BMI was 23.7

Among these 97 individuals, 75 were included in the intervention trial.
The age distribution among these 75 participants: 50 to 59 years: 7 60 to 69 years: 18 70 to 79 years: 32 80 to 89 years: 17 90 to 99 years: 2 Mean height 152 cm Mean weight 56 kg Mean BMI 23.9
69 participants in the intervention trial had a prior history of knee treatment, and 6 had no such history.

Participant flow

A total of 100 participants were enrolled in this study. Three individuals diagnosed with deep vein thrombosis (DVT) through ultrasonography before duplex scanning for detecting varicose vein were excluded, leaving 97 participants for the evaluation of varicose vein prevalence.
From these 97 participants, 22 were excluded, resulting in 75 participants being included in the intervention trial.

Reasons for Exclusion and Number of Cases
Knee pain improved between consent for varicose vein examination and intervention: 9　　Preference for varicose vein surgery: 2　　Rheumatoid arthritis (RA): 1　　Pain attributed to trauma or meniscal injury: 2　　Pain attributed to osteonecrosis of the femoral condyle: 1　　Decreased walking ability during intervention: 2　　Dementia: 1　　No follow-up visits: 3　　Relocation: 1


A total of 75 participants were enrolled in the intervention trial. 75 participants were divided into Varicose Vein Group (n=53) or No Varicose Vein Group (n=22).

### Varicose Vein Group (n=53)
Six participants were excluded due to difficulty during the initial stocking application practice (one of six due to itchiness), leaving 47 participants. The clinical course for these 47 participants is as follows:
##Participants with Improved Knee Pain (n=31)
-Discontinued due to complication (skin irritation): 1
-Discontinued due to preference for total knee arthroplasty (TKA): 1
-Discontinued due to a knee injury: 1
-Discontinued due to difficulty using the stockings: 1
-Discontinued due to a desire to end clinic visits: 6
-Continued until study completion: 21
##Participants with No Improvement in Knee Pain (n=17)
-Discontinued due to persistent knee pain: 14
-Discontinued due to difficulty using the stockings: 2


###No Varicose Vein Group (n=22)
Four participants were excluded due to difficulty during the initial stocking application practice, leaving 18 participants. The clinical course for these 18 participants is as follows:
##Participant with Improved Knee Pain (n=1)
-Discontinued due to a desire to end clinic visits: 1
##Participants with No Improvement in Knee Pain (n=17)
-Discontinued due to persistent knee pain: 16
-Continued until study completion: 1

Adverse events

Complications (skin irritation)　　Itchiness: 1 Skin irritation: 1

Outcome measures

# Treatment outcomes were divided into four groups based on patients outcome interview
Groups
1. Excellent improvement : Showing improved knee pain with objective changes, including decreased pain medication usage or improved activities of daily living
2. Improvement : Showing improved subjective knee pain
3. Improvement in legs : Showing improvement in some symptoms such as edema of the lower legs or movement of legs, but not knee pain
4. Unchanged


1 and 2 were classified as the group with improved knee pain, whereas 3 and 4 were classified as the group with no improvement in knee pain.

# Knee pain was self-assessed using the Numeric Rating Scale (NRS) and the Knee injury and Osteoarthritis Outcome Score (KOOS).

# Statistical analysis was performed using Fishers exact test or the Wilcoxon signed-rank sum test.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2023

Year

01

Month

20

Day

Date of IRB

2023

Year

03

Month

10

Day

Anticipated trial start date

2023

Year

03

Month

10

Day

Last follow-up date

2024

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

02

Month

01

Day

Last modified on

2025

Year

03

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064872

Single case data URL

Value
https://center6.umin.ac.jp/ice/64872