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

NCT04148950 | Completed DMC

• 1 other identifier: E.50.0.05.00/17
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from Baseline Edema at 4 weeks

  Baseline and week 4

• Change from Baseline Functional Capacity at 4 weeks

  Baseline and week 4

• Change From Baseline Short Form-36 at Week 4

  Baseline and week 4

Study Arms (2)

Kinesio Taping

EXPERIMENTAL

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: Exercise Program

Compression Stockings

ACTIVE COMPARATOR

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: Exercise Program

Interventions

Kinesio Tape OTHER

Also known as: Medical Adhesive Tape

Kinesio Taping

Compression Stockings OTHER

Also known as: Elastic Compression Stockings

Compression Stockings

Exercise Program OTHER

Compression Stockings; Kinesio Taping

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

Location

Related Publications (9)

• 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. doi: 10.1016/j.annepidem.2004.05.015.

  PMID: 15723761 BACKGROUND

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

  PMID: 25114187 BACKGROUND

• 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.

  PMID: 4744789 BACKGROUND

• 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. doi: 10.3949/ccjm.72.4.312.

  PMID: 15850243 BACKGROUND

• 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.

  PMID: 12372312 BACKGROUND

• 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.

  PMID: 12091180 BACKGROUND

• 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.

  PMID: 12563216 RESULT

• 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.

  PMID: 11890075 RESULT

• 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.

  PMID: 23426563 RESULT

MeSH Terms

Conditions

Varicose Veins; Telangiectasis; Pain; Edema

Interventions

Athletic Tape; Stockings, Compression; Resistance Training

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Compression Bandages; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Baha Naci, PT, MSc

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Semiramis Ozyilmaz, Assoc. Prof.

  Bezmialem Vakif University

  STUDY DIRECTOR

• Zerrin Yigit, MD, Prof.

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

TU (1)