Varicose Veins of Lower Limb Clinical Trial
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
NCT number | NCT04148950 |
Other study ID # | E.50.0.05.00/17 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | June 2015 |
Verified date | March 2020 |
Source | Istanbul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | June 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University-Cerrahpasa, Institute of Cardiology | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University |
Turkey,
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 — View 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. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation
Piazza G. Varicose veins. Circulation. 2014 Aug 12;130(7):582-7. doi: 10.1161/CIRCULATIONAHA.113.008331. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
Baseline and week 4 | |
Secondary | 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. | Baseline and week 4 | |
Secondary | 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. | Baseline and week 4 |
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