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Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency

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. Identifier: NCT01501188
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Encarnación Aguilar Ferrandiz, Universidad de Granada

Brief Summary:
The purpose of this study is to analyze the effects of Kinesio Taping on gastrocnemius muscle activation during gait and on Range of ankle motion in postmenopausal females with Chronic Venous Insufficiency in initial stages in comparison to a placebo control group.

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Other: Kinesio Taping Other: Placebo kinesio taping Phase 1

Detailed Description:
Chronic Venous Insufficiency (CVI) is a very common disease. Patients with this pathology present peripheral muscle pump impairment and restricted range of ankle motion. Few data are available on the use in chronic venous insufficiency patients of Kinesio Taping, a physical therapist's elastic dressing that permits action on muscle activity and joint range.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study on the Effect of Kinesio Taping on Bioelectrical Activity of Gastrocnemius Muscles and Range of Ankle Motion in Post-menopausal Women With Chronic Venous Insufficiency
Study Start Date : September 2008
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: Kinesio taping
Specific type of muscle and joint taping
Other: Kinesio Taping
The participants were randomly assigned to an experimental group, to received Kinesio Taping application for gastrocnemius muscle enhancement and functional correction of the ankle.The treatment was performed three times a week during a 4-week period.
Other Name: Neuromuscular tape

Placebo Comparator: Kinesio taping placebo
Kinesio taping placebo
Other: Placebo kinesio taping
Placebo-control group received treatment with a sham Kinesio Taping protocol to enhance gastrocnemius muscle function and dorsal ankle flexion.The strips used in this group did not follow the principles of tension and anatomic distribution of Kinesio technique.The treatment was performed three times a week during a 4-week period
Other Name: Neuromuscular taping placebo

Primary Outcome Measures :
  1. Change on surface electromyography in gastrocnemius muscles [ Time Frame: At baseline and 4 weeks. ]
    Muscle activity data during gait is sampled at 1600 Hz by surface electromyography, applying electrodes at medial gastrocnemius and lateral gastrocnemius level in both legs. We follow Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) guidelines for electrode placement and signal processing methods. The patient is instructed on the gait speed. After setting the speed-metronome, the electromyography image and activity is recorded for a total of seven seconds and expressed in microvolts units

  2. Change on range of ankle motion [ Time Frame: Baseline and 4 weeks ]
    This variable is measured by using a digital goniometer(SG 110, Penny and Giles Biometrics Ltd;UK) during maximum dorsal and plantar flexion.A sensor is placed at 10 cm from the internal malleolus and another on the inner side of the foot, parallel to the axial axis and perpendicular to the tibial axis.The machine records the degrees of plantar and dorsal flexion from the neutral position of the ankle.

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 50 and 75 years.
  • Mild-moderate Chronic Venous Insufficiency (grades C1, C2, and C3 on clinical-etiologic-anatomic-pathophysiologic (CEAP) scale)

Exclusion Criteria:

  • Chronic Venous Insufficiency (> grade C3)
  • Arterial disorders
  • Cardiorespiratory disease
  • Contraindications for Kinesio Taping technique including thrombosis, wounds, severe trauma, generalized edema secondary to cardiac or renal problems, carcinomas, intolerability of/allergy to surgical tape and 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 identifier (NCT number): NCT01501188

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University of Granada
Granada, Spain, 18001
Sponsors and Collaborators
Universidad de Granada
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Principal Investigator: Carmen Moreno, PhD Universidad de Granada

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Responsible Party: Encarnación Aguilar Ferrandiz, Research and teaching staff of the University of Granada, Universidad de Granada Identifier: NCT01501188     History of Changes
Other Study ID Numbers: UGR-409
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Keywords provided by Encarnación Aguilar Ferrandiz, Universidad de Granada:
Chronic Venous Insufficiency
Kinesio Taping
Range of ankle motion
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases