Back to resultsEfficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency
Primary Purpose
Chronic Venous Insufficiency
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Kinesio Taping
Placebo kinesio taping
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring Chronic Venous Insufficiency, Kinesio Taping, Electromyography, Range of ankle motion
Eligibility 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.
Sites / Locations
- University of Granada
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Kinesio taping
Kinesio taping placebo
Arm Description
Specific type of muscle and joint taping
Kinesio taping placebo
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01501188
Brief Title
Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
Keywords
Chronic Venous Insufficiency, Kinesio Taping, Electromyography, Range of ankle motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
259 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinesio taping
Arm Type
Experimental
Arm Description
Specific type of muscle and joint taping
Arm Title
Kinesio taping placebo
Arm Type
Placebo Comparator
Arm Description
Kinesio taping placebo
Intervention Type
Other
Intervention Name(s)
Kinesio Taping
Other Intervention Name(s)
Neuromuscular tape
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo kinesio taping
Other Intervention Name(s)
Neuromuscular taping placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Change on surface electromyography in gastrocnemius muscles
Description
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
Time Frame
At baseline and 4 weeks.
Title
Change on range of ankle motion
Description
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.
Time Frame
Baseline and 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Moreno, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18001
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency
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