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

• ClinicalTrials.gov Identifier: NCT04148950
• Recruitment Status: Completed
• First Posted: November 4, 2019
• Last Update Posted: March 5, 2020
• Sponsor: Istanbul University
• Information provided by (Responsible Party): Baha Naci, Istanbul University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Varicose Veins of Lower Limb; Varicose Veins and Edema of Leg; Chronic Venous Hypertension Peripheral; Spider Veins; Telangiectasia	Other: Kinesio Tape; Other: Compression Stockings; Other: Exercise Program	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 2013
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Kinesio Taping; 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; Other Name: Medical Adhesive Tape; Other: Exercise Program
Active Comparator: Compression Stockings; 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; Other Name: Elastic Compression Stockings; Other: Exercise Program

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline Pain at 4 weeks [ Time Frame: Baseline and week 4 ]
   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".

Secondary Outcome Measures :

1. Change from Baseline Edema at 4 weeks [ Time Frame: Baseline and week 4 ]

   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.

2. Change from Baseline Functional Capacity at 4 weeks [ Time Frame: Baseline and week 4 ]
   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.
3. Change From Baseline Short Form-36 at Week 4 [ Time Frame: Baseline and 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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 75 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, Turkey

Sponsors and Collaborators

Istanbul University

Investigators

• Principal Investigator: Baha Naci, PT, MSc; Istanbul University-Cerrahpasa
• Study Director: Semiramis Ozyilmaz, Assoc. Prof.; Bezmialem Vakif University
• Study Chair: Zerrin Yigit, MD, Prof.; Istanbul University-Cerrahpasa

More Information

Publications of Results:

Ibegbuna V, Delis KT, Nicolaides AN, Aina O. Effect of elastic compression stockings on venous hemodynamics during walking. J Vasc Surg. 2003 Feb;37(2):420-5.

Orsted HL, Radke L, Gorst R. The impact of musculoskeletal changes on the dynamics of the calf muscle pump. Ostomy Wound Manage. 2001 Oct;47(10):18-24. Review.

Aguilar-Ferrándiz ME, Castro-Sánchez AM, Matarán-Peñarrocha GA, Guisado-Barrilao R, García-Ríos 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.

Other Publications:

Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. Review.

Piazza G. Varicose veins. Circulation. 2014 Aug 12;130(7):582-7. doi: 10.1161/CIRCULATIONAHA.113.008331. Review.

Coon WW, Willis PW 3rd, Keller JB. Venous thromboembolism and other venous disease in the Tecumseh community health study. Circulation. 1973 Oct;48(4):839-46.

Bartholomew JR, King T, Sahgal A, Vidimos AT. Varicose veins: newer, better treatments available. Cleve Clin J Med. 2005 Apr;72(4):312-4, 319-21, 325-8. Review.

Cools AM, Witvrouw EE, Danneels LA, Cambier DC. Does taping influence electromyographic muscle activity in the scapular rotators in healthy shoulders? Man Ther. 2002 Aug;7(3):154-62.

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

• Responsible Party: Baha Naci, Principal Investigator, Istanbul University
• ClinicalTrials.gov Identifier: NCT04148950
• Other Study ID Numbers: E.50.0.05.00/17
• First Posted: November 4, 2019
• Last Update Posted: March 5, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baha Naci, Istanbul University:

Chronic Venous Disease; Kinesio Taping; Compression Stockings; Pain; Edema; Functional Capacity

Additional relevant MeSH terms:

Telangiectasis; Varicose Veins; Edema; Vascular Diseases; Cardiovascular Diseases