Varicose Veins of Lower LimbNCT04148950
Effects of Kinesio Taping Method on Functional Capacity and Quality of Life in Patients With Chronic Venous Disease
A study testing Kinesio Tape, Compression Stockings and Exercise Program in people with Varicose Veins of Lower Limb and Varicose Veins and Edema of Leg, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Varicose Veins of Lower Limb, Varicose Veins and Edema of Leg, Chronic Venous Hypertension Peripheral
- What is being tested?
- Kinesio Tape, Compression Stockings and Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Deep Vein Thrombosis
- Thrombophlebitis
- Active or healed venous ulcerations
- Hyperpigmentation
- Bleeding varicose veins
- Open wounds and acute infections
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Institute of Cardiology
Istanbul
About this study
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
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.
Read the 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
- Being tested
- Kinesio Tape, Compression Stockings, Exercise Program
- Keywords
- Chronic Venous Disease, Kinesio Taping, Compression Stockings, Pain, Edema, Functional Capacity
- Medical subject headings
- Varicose Veins, Telangiectasis, Pain, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapeOther
Also called Medical Adhesive Tape
Compression StockingsOther
Also called Elastic Compression Stockings
Exercise ProgramOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Compression Stockings; Other: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Baseline and week 4
Secondary outcomes (3)
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.
Measured: Baseline and week 4
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.
Measured: Baseline and week 4
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.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study startMay 2013
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baha Naci, Istanbul University
- Investigators
- Baha Naci, PT, MSc, Principal investigator, Istanbul University - CerrahpasaSemiramis Ozyilmaz, Assoc. Prof., Study director, Bezmialem Vakif UniversityZerrin Yigit, MD, Prof., Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148950
- Sponsor's protocol ID
- E.50.0.05.00/17
- Status last verified
- Mar 2020
- First submitted
- 31 Oct 2019
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15723761Piazza G. Varicose veins. Circulation. 2014 Aug 12;130(7):582-7. doi: 10.1161/CIRCULATIONAHA.113.008331. No abstract available.
PubMed 25114187Coon 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.
PubMed 4744789Bartholomew 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.
PubMed 15850243Cools 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.
PubMed 12372312ATS 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.
PubMed 12091180Ibegbuna 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.
PubMed 12563216Orsted 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.
PubMed 11890075Aguilar-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.
PubMed 23426563
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04148950
- Acronym / sponsor ID
- E.50.0.05.00/17
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping | Experimental | Other: Kinesio Tape, Other: Exercise ProgramKinesio 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 | Active comparator | Other: Compression Stockings, Other: Exercise ProgramCompression 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Deep Vein Thrombosis
- Thrombophlebitis
- Active or healed venous ulcerations
- Hyperpigmentation
- Bleeding varicose veins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio TapeAlso: Medical Adhesive Tape | Other | Kinesio Taping |
| Compression StockingsAlso: Elastic Compression Stockings | Other | Compression Stockings |
| Exercise Program | Other | Compression Stockings, Kinesio Taping |
Primary outcome
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".
3 secondary outcomes
Change from Baseline Edema at 4 weeks
Time frame: Baseline and week 4
Change from Baseline Functional Capacity at 4 weeks
Time frame: Baseline and week 4
Change From Baseline Short Form-36 at Week 4
Time frame: Baseline and week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Background: PubMed 15723761Beebe-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.
- Background: PubMed 25114187Piazza G. Varicose veins. Circulation. 2014 Aug 12;130(7):582-7. doi: 10.1161/CIRCULATIONAHA.113.008331. No abstract available.
- Background: PubMed 4744789Coon 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.
- Background: PubMed 15850243Bartholomew 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.
- Background: PubMed 12372312Cools 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.
- Background: PubMed 12091180ATS 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.
- Results publication: PubMed 12563216Ibegbuna 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 publication: PubMed 11890075Orsted 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 publication: PubMed 23426563Aguilar-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baha Naci, PT, MSc principal investigator
Istanbul University - Cerrahpasa
Semiramis Ozyilmaz, Assoc. Prof. study director
Bezmialem Vakif University
Zerrin Yigit, MD, Prof. study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Tape, Compression Stockings and Exercise Program in people with Varicose Veins of Lower Limb and Varicose Veins and Edema of Leg, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pain at 4 weeks (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04148950, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.