Effects of Kinesio Taping Method on Functional Capacity and Quality of Life in Patients With Chronic Venous Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Compression Stockings and Kinesio Taping Method on Pain, Edema, Functional Capacity and Quality of Life in Patients With Chronic Venous Disease

Conditions
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Varicose Veins of Lower Limb, Varicose Veins and Edema of Leg, Chronic Venous Hypertension Peripheral, Spider Veins, Telangiectasia

Intervention / Treatment
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* Other: Kinesio Tape
* Other: Compression Stockings
* Other: Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesio Taping<br>Kinesio Taping group consisted of 29 patients with CVD. Kinesio Taping was applied once a week for a period of 4 weeks. Closed Fan and Closed Basketweave techniques were applied according to the clinical manifestations, intensity of symptoms, and the needs for the areas to be taped. Basketweave technique was used generally for the thigh, and the areas rich in lymph nodes while closed fan technique was used for cruris, and regions of less severe venous reflux or obstruction. Kinesio Taping was slowly removed by the patient 4 days after the application to prevent any allergic reactions. In addition, patients were given calf muscle pump exercises, flexibility exercises, diaphragmatic breathing exercises, and lower extremity elevation. | Other: Kinesio Tape<br> <br> * Other names: Medical Adhesive Tape;Other: Exercise Program<br> <br> |
| Active Comparator: Compression Stockings<br>Compression stockings group consisted of 29 patients with CVD. Patients were recommended medium pressure (23-32 mmHg) compression stockings by the physician. Knee high or thigh high compression stockings were given according to the level of symptoms and signs. In addition, patients were given calf muscle pump exercises, flexibility exercises, diaphragmatic breathing exercises, and lower extremity elevation. | Other: Compression Stockings<br> <br> * Other names: Elastic Compression Stockings;Other: Exercise Program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain at 4 weeks | Intensity of pain was evaluated using the Visual Analogue Scale (VAS). VAS ranges from 0 mm indicating no pain to 100 mm indicating the worst pain possible. | Baseline and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Edema at 4 weeks | Peripheral edema was assesed in both lower limbs by using circumference measurement in four areas, including the ankle joint, the knee joint, the widest region of the calf and the widest region of the thigh. A flexible, inelastic, 7 mm-wide tape measure with a sensitivity degree of 0.1 cm was used for the measurements. | Baseline and week 4 | 
| Change from Baseline Functional Capacity at 4 weeks | Exercise capacity was measured with the 6 Minute Walk Test (6MWT) according to the ATS guidelines. The 6 minutes wallking distance (6MWD) was recorded in meters. Higher scores indicate a better outcome. | Baseline and week 4 | 
| Change From Baseline Short Form-36 at Week 4 | Short Form-36 [SF-36] (0-100) was performed to assess generic quality of life (QOL). SF-36 consists of 36 items and 8 subscales. These subscales are physical functioning, role functioning physical, bodily pain, general health perception, vitality, social functioning, role functioning emotional, and mental health. The eight subscales are also summarized into mental component summary and physical component summary scores. Mental component summary contains the subscores of vitality, social functioning, role-emotional, and mental health. Physical component summary contains the subscores of physical functioning, role-physical, bodily pain, and general health. All the scores range from 0 to 100. Higher scores indicate better quality of life. | Baseline and week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Venous Disease, Kinesio Taping, Compression Stockings, Pain, Edema, Functional Capacity