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CTRI Number  CTRI/2024/07/070708 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Buergers Exercise with Manual Lymphatic Drainage for Varicose Veins A Randomized Clinical Trial 
Scientific Title of Study   EFFECT OF BUERGERS EXERCISE Vs MANUAL LYMPHATIC DRAINAGE IN SUBJECTS WITH VARICOSE VEINS- A RANDOMIZED CLINICAL TRIAL  
Trial Acronym  Not applicable  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Samudre 
Designation  Student  
Affiliation  Kle institute of physiotherapy  
Address  Kle college of physiotherapy,cvts department of physiotherapy,nehru nagar,belgavi- Karnataka
Kle college of physiotherapy, Nehru Nagar,belgavi- Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  09511716890  
Fax    
Email  aditisamudre11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Ganesh.B.R 
Designation  Professor and Head of department  
Affiliation  Kle institute of physiotherapy  
Address  Kle college of physiotherapy,cvts department of physiotherapy, nehru nagar belgavi- Karnataka
Kle college of physiotherapy, cvts department of physiotherapy, nehru nagar belgavi-Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  9844857581  
Fax    
Email  ganeshbr@klekipt.edu.in  
 
Details of Contact Person
Public Query
 
Name  Aditi Samudre 
Designation  Student  
Affiliation  Kle institute of physiotherapy  
Address  Kle college of physiotherapy, Cvts department of physiotherapy,nehru nagar, belgavi-Karnataka
Kle college of physiotherapy belgavi
Belgaum
KARNATAKA
590010
India 
Phone  09511716890  
Fax    
Email  aditisamudre11@gmail.com  
 
Source of Monetary or Material Support  
Kle institute of physiotherapy,cvts department of physiotherapy,nehru nagar belgavi- 590010 Karnataka, India  
 
Primary Sponsor  
Name  Aditi Samudre  
Address  KLE Institute of physiotherapy,Cvts department of physiotherapy,nehru nagar belgavi-590010 karnataka, India  
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrGanesh BR  Kle institute of physiotherapy   Kle institute of physiotherapy,cvts department of physiotherapy,belgavi-590010,Karnataka India
Belgaum
KARNATAKA 
9844857581

ganeshbr@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and ethics committee,Kle institute of physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I831||Varicose veins of lower extremities with inflammation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Effect of burgers exercise vs manual lymphatic drainage in subjects with varicose veins   Baseline assessments will be conducted on day 1 prior to the treatment and post-intervention assessments will be conducted after a month following the intervention which will include visual analogue scale, 6 min walk test, Pitting oedema grades , and chronic venous insufficiency quality of life questionnaire. The intervention will be given for each Group for 6 days in 1 week for a month 
Intervention  Effect of burgers exercise vs manual lymphatic drainage in subjects with varicose veins   Burgers exercise vs manual lymphatic drainage  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Age group 35-55 years of all gender.
Diagnosed with Varicose Veins.
Oedema grade ≥ 2.
Willing to participate in the study 
 
ExclusionCriteria 
Details  Deep Vein Thrombosis (DVT)
Undergone with recent surgical interventions in lower limb
Recent lower limb fractures.
Any Neuropathies or ulcers in lower limb 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
6 min walk test
CIVIQ-20
Pitting Oedema scale  
Baseline and after 1 month of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Visual analogue scale   Baseline & after 1 month of intervention  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/07/2024 
Date of Study Completion (India) 01/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/04/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Varicose veins often contain a one-way valve that closes when muscle contraction occurs, allowing blood to flow exclusively up the leg as in normal veins. In contrast, the valves in varicose. 

Veins are not operating correctly. As a result, valves malfunction and blood might flow in four different ways. We refer to this blood flow backward as venous reflux. As a result, blood builds up in the legs, resulting in varicose veins. 

Widening, tortuous superficial veins in the legs subcutaneous tissues are known as varicose veins, and they are frequently very noticeable. These often have a size more than 3 mm. They are typically found inside and are five times larger. 

Women are more likely than men to have varicose veins. Patients who exhibit signs of noticeable dark blue blood vessels, particularly in the legs and feet, or who have a history of being in contact with risk factors. Assessment is necessary for diagnosis, and it is carried out via colour Doppler imaging and palpation. 
 
Risk factors in varicose veins can be classified as hormonal, lifestyle, acquired, and inherited.

Venous hypertension or thrombosis may be the cause of venous disease. Although there may be overlap with venous thrombosis because this can also result in venous hypertension, hypertension is the cause of what is known as chronic venous illness. Although pelvic venous diseases (PeVDs) and postthrombotic syndrome (PTS) are two underlying causes of chronic venous disease, the former is frequently the major cause. 
        Furthermore, there are conditions like lipedema and lymphedema that are frequently misdiagnosed.
The general population is afflicted with chronic venous disease (CVD), a disorder that significantly lowers quality of life. Some of the disease’s symptoms are less distinct, but varicose veins and venous ulcers are typically the most noticeable indicators.
 Pain is the symptom that drives CVD sufferers to seek medical attention the most often, among the other symptoms that include heaviness, edema, muscular cramps, and restless legs. Nonetheless, there is a significant disparity in the degree of pain and clinically discernible indicators.
 
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