Chronic Venous InsufficiencyPhase 1NCT01501188
Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency
A Phase 1 study testing Kinesio Taping in people with Chronic Venous Insufficiency, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Kinesio Taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2008to Sep 2012
- Phase
- Phase 1
- 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 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 75 years.
- Mild-moderate Chronic Venous Insufficiency (grades C1, C2, and C3 on clinical-etiologic-anatomic-pathophysiologic (CEAP) scale)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Kinesio Taping, Placebo kinesio taping
- Keywords
- Chronic Venous Insufficiency, Kinesio Taping, Electromyography, Range of ankle motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingOther
Also called Neuromuscular tape
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 tapingOther
Also called Neuromuscular taping placebo
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
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping | Experimental | Specific type of muscle and joint taping Receives: Other: Kinesio Taping |
| Kinesio taping placebo | Placebo comparator | Kinesio taping placebo Receives: Other: Placebo kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and 4 weeks.
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startSep 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Encarnación Aguilar Ferrandiz, Universidad de Granada
- Investigators
- Carmen Moreno, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501188
- Sponsor's protocol ID
- UGR-409
- Status last verified
- May 2015
- First submitted
- 21 Dec 2011
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01501188
- Acronym / sponsor ID
- UGR-409
- Conditions
- Chronic Venous Insufficiency
- Keywords
- Chronic Venous Insufficiency, Kinesio Taping, Electromyography, Range of ankle motion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Dec 2011 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping | Experimental | Other: Kinesio TapingSpecific type of muscle and joint taping |
| Kinesio taping placebo | Placebo comparator | Other: Placebo kinesio tapingKinesio taping placebo |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 50 and 75 years.
- Mild-moderate Chronic Venous Insufficiency (grades C1, C2, and C3 on clinical-etiologic-anatomic-pathophysiologic (CEAP) scale)
Key exclusion criteria (4 listed)
- 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.
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 TapingAlso: Neuromuscular tapeThe 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 | Kinesio taping |
| Placebo kinesio tapingAlso: Neuromuscular taping placeboPlacebo-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 | Kinesio taping placebo |
Primary outcome
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
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.
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 29 May 2015.
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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.
Carmen Moreno, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kinesio Taping in people with Chronic Venous Insufficiency, run by Universidad de Granada at 1 site in Spain.
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 2 inclusion and 4 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 29 May 2015. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 on surface electromyography in gastrocnemius muscles (time frame: At baseline and 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2015.