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临床试验/CTRI/2024/07/070705
CTRI/2024/07/070705已完成4 期

To Evaluate the Effect of Cold Leg Pack on Pain Management in Adults among Varicose Vein Patients - A Randomized Controlled trial

Dr J Busrath Sabeena1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

Varicose veins is that in which lower leg subcutaneous veins that have become convoluted, enlarged, and strained. Western and developed nations have a higher prevalence of this illness. Blood reflux in the lower leg veins is caused by inadequate valves. Varicose veins are currently reported to impact 2%–73% of the world’s population. One of the important hydrotherapy treatment for varicose vein is the cold leg pack. It is a simple, affordable, and effective way to treat and manage a variety of chronic conditions. the application of cold water to the afflicted region improve circulation and reduce swelling and inflammation. A randomized controlled trial design will be adopted for this study. All the eligible subjects  of sample size 80 will be divided into two groups, study group and control group by simple randomization. The study group will have  Yoga and naturopathic treatments along with cold leg pack for 20 minutes a day for 4 days in a week for 5 weeks and control group with Yoga and Naturopathy treatments other than cold leg pack intervention for a period of 4 days in a week for 5 weeks. Assessments will be done before the intervention after the intervention on day one and 5 weeks respectively. As a primary outcome the Visual Analog Scale will be assessed on the baseline and at the end of 5th week. The pain VAS is a unidimensional way to evaluate how much pain a patient is experiencing. It may also be used to compare how much pain individuals with comparable diseases are experiencing. As a secondary outcome the Venous Clinical Severity Score and Manual Perforator  Incompetence test  will be assessed  on baseline and at end of 5th week. Venous clinical severity score (VCSS) calculator is used to track changes in the severity of venous illness. Aching, heaviness, and varicose veins that are larger than 4 millimeters are the items graded in the VCSS. Perform the Manual compression test by having the patient stand and placing the right hand over the distal lower part of the suspected vein and left hand over the proximal vein. Hands will be about 15-20 cm apart, compress the proximal portion of the vein, feels a pulse in distal hand, test is positive.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
45.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients positive for manual perforator incompetence test with dilated veins larger than four millimeter under one to fourth stage and willing to give consent are included.

排除标准

  • Patients with Sciatica, Leg Fracture , varicose vein of severe stages, Superficial and deep vein thrombosis, deep Valvular incompetence are excluded.

结局指标

主要结局

Visual Analog Scale

时间窗: Baseline and 5th week

次要结局

  • Venous Clinical Severity Score and Manual perforator Incompetence Test(Baseline and 5th week)

研究者

发起方
Dr J Busrath Sabeena
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr J Busrath Sabeena

International Institute of yoga and Naturopathy Medical Sciences

研究点 (1)

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