| 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
|
|
|
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
|
|
|
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. |