Clinical trial NCT04148950: Effects of Kinesio Taping Method on Functional Capacity and Quality of Life in Patients With Chronic Venous Disease
Official title: Effects of Compression Stockings and Kinesio Taping Method on Pain, Edema, Functional Capacity and Quality of Life in Patients With Chronic Venous Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins of Lower Limb
Varicose Veins and Edema of Leg
Chronic Venous Hypertension Peripheral
Spider Veins
Telangiectasia
Keywords: Chronic Venous Disease
Kinesio Taping
Compression Stockings
Pain
Edema
Functional Capacity
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 58
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomised and controlled study is to investigate the effects of Kinesio Taping method and compression stockings, combined with exercise therapy, on pain, edema, functional capacity and quality of life in patients with chronic venous disease. Therefore, the study compares effectiveness of these two methods for chronic venous disease.

Detailed description: Chronic venous disease (CVD), an important cause of morbidity, is one of the most commonly reported chronic medical conditions. Venous hypertension in the lower limbs caused by venous reflux, venous obstruction or calf muscle pump failure is the main pathophysiological mechanism of CVD. The incidence of varicose veins in population varies with geographic region, age, gender and risk factors. The prevalence of trunk varicose veins has been reported 25.9% in women and 12.9% in men. Symptoms include leg pain, edema, pruritus, discomfort, trophic skin changes, venous ulcerations. Reduced quality of life, and limited activities of daily living have been reported due to the symptoms in patients with CVD.

Compression therapies play a major role in the treatment of CVD. Elastic compression stockings reduces residual volume fraction by promoting calf muscle pump function and reducing venous reflux. Periodic contractions of the gastrocnemius muscle has also beneficial impacts on improving calf muscle pump function and reducing venous stasis.

Kinesio Taping, developed by Dr. Kenzo Kase, is a taping method applied for supporting muscle function, correcting joint misalignment, improving lymph and blood flow, decreasing pain and edema. Kinesio Taping increases cutaneous and subcutaneous area by lifting the skin, thus improves movement and circulation. Mixed Kinesio Taping-compression model has been reported to improve venous symptoms, peripheral venous flow, disease severity and quality of life in patients with mild CVD.

Studies comparing conservative treatment techniques and investigating functional capacity in patients with CVD are very limited despite the high prevalence of disease. Therefore, the investigators planned this study to examine the effects of Kinesio Taping method and compression stockings on pain, edema, functional capacity and quality of lifein patients with CVD.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with primary chronic venous disease after Doppler Ultrasonographic assessment by the physician
* Presence of clinical symptoms of chronic venous disease
* Patients with C1 (telangiectasias, reticular veins), C2 (varicose veins) or C3 (edema) clinical classes of CEAP (clinical, etiologic, anatomic, pathophysiologic) classification system
* Patients not using medication for the treatment of chronic venous disease
* No prior varicose vein surgery
* Being volunteer for participating in the research
* Signing the written informed consent form prior to participation in the study

Exclusion Criteria:

* Deep Vein Thrombosis
* Thrombophlebitis
* Active or healed venous ulcerations
* Hyperpigmentation
* Bleeding varicose veins
* Open wounds and acute infections
* Acute decompensated heart failure
* Uncontrolled hypertension
* Severe cognitive impairment
* Patients with poor adherence to the treatment program
* Allergic reaction to polyacrylate forms of medical adhesives
* Pregnancy

Primary outcomes:
measure: Change from Baseline Pain at 4 weeks
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Change from Baseline Edema at 4 weeks
timeFrame: Baseline and week 4
measure: Change from Baseline Functional Capacity at 4 weeks
timeFrame: Baseline and week 4
measure: Change From Baseline Short Form-36 at Week 4
timeFrame: Baseline and week 4
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Institute of Cardiology
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Baha Naci, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Semiramis Ozyilmaz, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Zerrin Yigit, MD, Prof.
role: STUDY_CHAIR
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citation: Aguilar-Ferrandiz ME, Castro-Sanchez AM, Mataran-Penarrocha GA, Guisado-Barrilao R, Garcia-Rios MC, Moreno-Lorenzo C. A randomized controlled trial of a mixed Kinesio taping-compression technique on venous symptoms, pain, peripheral venous flow, clinical severity and overall health status in postmenopausal women with chronic venous insufficiency. Clin Rehabil. 2014 Jan;28(1):69-81. doi: 10.1177/0269215512469120. Epub 2013 Feb 20.