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

Chronic Venous Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501188
• Other study ID #: UGR-409
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2011
• Last updated: May 28, 2015
• Start date: September 2008
• Est. completion date: September 2012

Study information

• Verified date: May 2015
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

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.
• 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

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on surface electromyography in gastrocnemius muscles	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	At baseline and 4 weeks.	No
Primary	Change on range of ankle motion	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.	Baseline and 4 weeks	No