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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04148950
Recruitment Status : Completed
First Posted : November 4, 2019
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Baha Naci, Istanbul University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148950


Locations
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Turkey
Istanbul University-Cerrahpasa, Institute of Cardiology
Istanbul, Turkey
Sponsors and Collaborators
Istanbul University
Investigators
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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
Publications of Results:
Other Publications:
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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    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020

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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:
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Telangiectasis
Varicose Veins
Edema
Vascular Diseases
Cardiovascular Diseases