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

NCT ID: NCT04148950

Last Updated: 2020-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Kinesio Tape

Intervention Type: OTHER

Exercise Program

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Compression Stockings

Intervention Type: OTHER

Exercise Program

Intervention Type: OTHER

Interventions

Kinesio Tape

Intervention Type: OTHER

Compression Stockings

Intervention Type: OTHER

Exercise Program

Intervention Type: OTHER

Other Intervention Names

Medical Adhesive Tape; Elastic Compression Stockings

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Baha Naci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baha Naci, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Semiramis Ozyilmaz, Assoc. Prof.

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Zerrin Yigit, MD, Prof.

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

PMID: 15723761 (View on PubMed)

Piazza G. Varicose veins. Circulation. 2014 Aug 12;130(7):582-7. doi: 10.1161/CIRCULATIONAHA.113.008331. No abstract available.

Reference Type: BACKGROUND

PMID: 25114187 (View on PubMed)

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. doi: 10.1161/01.cir.48.4.839. No abstract available.

Reference Type: BACKGROUND

PMID: 4744789 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15850243 (View on PubMed)

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. doi: 10.1054/math.2002.0464.

Reference Type: BACKGROUND

PMID: 12372312 (View on PubMed)

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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

Reference Type: BACKGROUND

PMID: 12091180 (View on PubMed)

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. doi: 10.1067/mva.2003.104.

Reference Type: RESULT

PMID: 12563216 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11890075 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23426563 (View on PubMed)

Other Identifiers

E.50.0.05.00/17

Identifier Type: -

Identifier Source: org_study_id