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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio Tape
Compression Stockings
Exercise Program
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins of Lower Limb focused on measuring Chronic Venous Disease, Kinesio Taping, Compression Stockings, Pain, Edema, Functional Capacity

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpasa, Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesio Taping

Compression Stockings

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 31, 2019
Last Updated
March 3, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04148950
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio Taping
Arm Type
Experimental
Arm Description
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.
Arm Title
Compression Stockings
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesio Tape
Other Intervention Name(s)
Medical Adhesive Tape
Intervention Type
Other
Intervention Name(s)
Compression Stockings
Other Intervention Name(s)
Elastic Compression Stockings
Intervention Type
Other
Intervention Name(s)
Exercise Program
Primary Outcome Measure Information:
Title
Change from Baseline Pain at 4 weeks
Description
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".
Time Frame
Baseline and week 4
Secondary Outcome Measure Information:
Title
Change from Baseline Edema at 4 weeks
Description
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.
Time Frame
Baseline and week 4
Title
Change from Baseline Functional Capacity at 4 weeks
Description
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.
Time Frame
Baseline and week 4
Title
Change From Baseline Short Form-36 at Week 4
Description
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.
Time Frame
Baseline and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baha Naci, PT, MSc
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Semiramis Ozyilmaz, Assoc. Prof.
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zerrin Yigit, MD, Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University-Cerrahpasa, Institute of Cardiology
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
15723761
Citation
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.
Results Reference
background
PubMed Identifier
25114187
Citation
Piazza G. Varicose veins. Circulation. 2014 Aug 12;130(7):582-7. doi: 10.1161/CIRCULATIONAHA.113.008331. No abstract available.
Results Reference
background
PubMed Identifier
4744789
Citation
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.
Results Reference
background
PubMed Identifier
15850243
Citation
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.
Results Reference
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PubMed Identifier
12372312
Citation
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.
Results Reference
background
PubMed Identifier
12091180
Citation
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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
Results Reference
background
PubMed Identifier
12563216
Citation
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.
Results Reference
result
PubMed Identifier
11890075
Citation
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.
Results Reference
result
PubMed Identifier
23426563
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.
Results Reference
result

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

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