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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Universidad de Granada.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Encarnación Aguilar Ferrandiz, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01501188
First received: December 21, 2011
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Chronic Venous Insufficiency
Other: Kinesio Taping
Other: Placebo kinesio taping
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Change on surface electromyography in gastrocnemius muscles [ Time Frame: At baseline and 4 weeks. ] [ Designated as safety issue: No ]
    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

  • Change on range of ankle motion [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501188

Contacts
Contact: MªEncarnacion ME Aguilar, PT +34669546384 encaguilar@hotmail.com
Contact: Adelaida Mª AM Castro, PhD +34689723203 adelaid@ual.es

Locations
Spain
University of Granada Recruiting
Granada, Spain, 18001
Contact: MªEncarnacion ME Aguilar, PT    +34669546384    encaguilar@hotmail.com   
Contact: Adelaida Mª AM Castro, PhD    +34689723203    adelaid@ual.es   
Sub-Investigator: MªEncarnacion ME Aguilar, PT         
Sub-Investigator: Adelaida Mª AM Castro Sanchez, PhD         
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Carmen Moreno, PhD Universidad de Granada
  More Information

No publications provided

Responsible Party: Encarnación Aguilar Ferrandiz, Research and teaching staff of the University of Granada, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01501188     History of Changes
Other Study ID Numbers: UGR-409
Study First Received: December 21, 2011
Last Updated: December 28, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
Chronic Venous Insufficiency
Kinesio Taping
Electromyography
Range of ankle motion

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014