BandagesPhase 1NCT02735408
Kinesiotape Tensiomyography in Low Back Region
A Phase 1 study testing Kinesiotape (KT) in people with Bandages and Muscle Tonus, run by Universidad Europea de Madrid at 2 sites in Spain.
Trial summary
Lumbar pain is a quite prevalent pathology in general population within general and sporting population, which comes to mean high sanitary and sport costs. This concrete pain´s nature is often unspecific, but it seems that one of the main risk factors that predispose to suffer from it are changes in the… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bandages, Muscle Tonus, Low Back Pain
- What is being tested?
- Kinesiotape (KT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2015to Sep 2016
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjets without exclusion criteria
- Workers from UEM
Who cannot join
- Low back conditions
Trial locations and contacts
2 sites in 1 country.
Mónica García, PT,MSc contact
Spain2 sites, 2 recruiting
- Recruiting
Universidad Europea
Madrid, Madrid
Mónica García, PT, MSc, monica.garcia@universidadeuropea.es
- Recruiting
Universidad Europea
Madrid, Madrid
Móncia García, PT, MSc, 620005953, monica.garcia@universidadeuropea.es
About this study
Official title: Tensiomyography Effects of the Kinesiotape Tension in the Muscular Stiffness of the Low Back Region
Lumbar pain is a quite prevalent pathology in general population within general and sporting population, which comes to mean high sanitary and sport costs. This concrete pain´s nature is often unspecific, but it seems that one of the main risk factors that predispose to suffer from it are changes in the paravertebral-lumbar musculature stiffness.
Since one decade approximately, it has proliferated, especially within sportsmen and women the use of a therapeutic technique: the neuromuscular bandage best known as Kinesiotape (KT). This treatment seems to accept different applications, despite there´s still a lack of scientific evidence for several of its supposed effects. One of the theories about its use technique is that the bandage strain generates different effects in musculature stiffness. Thus, when the bandage is applied over the skin with a pre-stretching of the elastic bandage, it can cause arise of stiffness and strength muscle empowerment. On the other hand, if the bandage is applied without strain, the opposite result would appear, relaxation and strength muscle decrease.
Read more
For trainers and therapists is important to know if the KT effect differs over the bandage technique, since the application could be different according to the specific troubles reported by the athletes. For example, talking about cyclists, who keep constantly a hold rachis lumbar flexion, could be interesting to normalize the lumbar musculature stiffness, by placing the bandage with certain strain to achieve a mechanic effect. Nevertheless, talking about other sports like weightlifting, the bandage effect should be the stiffness arisen as a preventive measure, for avoiding injuries derived from the lack of motor control in the lumbar region. These lumbar-region muscle problems affect to popular and majority sports like football, so lumbar pain is very frequently reported by football players, normally due to an agonist-antagonist musculature unbalance. In all these terms, the use of KT would be interesting in order to reduce the musculature strain degree.
Tensiomyography (TMG) is showing as one of the most useful and reliable instrument for the musculature stiffness assessing, due to its velocity, harmlessness, sensing and high reproducibility. Taking in consideration that the maximum deformity measured by the TMG is inversely related with the muscle stiffness, and whereas this project pretends to modify that stiffness by means of the KT application, it seems obvious that TMG is the most suitable measurement instrument.
All these precedents considered, the present project pretends to analyze the effects of different KT strain application along 48 hours with strains techniques of 100%, strain 50% and strain 0% in the normalization of the paravertebral-lumbar musculature stiffness, by means of TMG monitoring.
Read the detailed description
Lumbar pain is a quite prevalent pathology in general population within general and sporting population, which comes to mean high sanitary and sport costs. This concrete pain´s nature is often unspecific, but it seems that one of the main risk factors that predispose to suffer from it are changes in the paravertebral-lumbar musculature stiffness.
Since one decade approximately, it has proliferated, especially within sportsmen and women the use of a therapeutic technique: the neuromuscular bandage best known as Kinesiotape (KT). This treatment seems to accept different applications, despite there´s still a lack of scientific evidence for several of its supposed effects. One of the theories about its use technique is that the bandage strain generates different effects in musculature stiffness. Thus, when the bandage is applied over the skin with a pre-stretching of the elastic bandage, it can cause arise of stiffness and strength muscle empowerment. On the other hand, if the bandage is applied without strain, the opposite result would appear, relaxation and strength muscle decrease.
For trainers and therapists is important to know if the KT effect differs over the bandage technique, since the application could be different according to the specific troubles reported by the athletes. For example, talking about cyclists, who keep constantly a hold rachis lumbar flexion, could be interesting to normalize the lumbar musculature stiffness, by placing the bandage with certain strain to achieve a mechanic effect. Nevertheless, talking about other sports like weightlifting, the bandage effect should be the stiffness arisen as a preventive measure, for avoiding injuries derived from the lack of motor control in the lumbar region. These lumbar-region muscle problems affect to popular and majority sports like football, so lumbar pain is very frequently reported by football players, normally due to an agonist-antagonist musculature unbalance. In all these terms, the use of KT would be interesting in order to reduce the musculature strain degree.
Tensiomyography (TMG) is showing as one of the most useful and reliable instrument for the musculature stiffness assessing, due to its velocity, harmlessness, sensing and high reproducibility. Taking in consideration that the maximum deformity measured by the TMG is inversely related with the muscle stiffness, and whereas this project pretends to modify that stiffness by means of the KT application, it seems obvious that TMG is the most suitable measurement instrument.
All these precedents considered, the present project pretends to analyze the effects of different KT strain application along 48 hours with strains techniques of 100%, strain 50% and strain 0% in the normalization of the paravertebral-lumbar musculature stiffness, by means of TMG monitoring.
- Conditions
- Bandages, Muscle Tonus, Low Back Pain
- Being tested
- Kinesiotape (KT)
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotape (KT)Other
| Study group | Role | What they receive |
|---|---|---|
| 100% KT Tension | Experimental | 100% KT Tension Receives: Other: Kinesiotape (KT) |
| 50% KT Tension | Experimental | 50% KT Tension Receives: Other: Kinesiotape (KT) |
| 0% KT Tension | Experimental | 0% KT Tension Receives: Other: Kinesiotape (KT) |
| Control (Without KT) | No intervention | Control (Without KT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tensiomyography changes (seconds): Delay time (Td) ; Contraction time (Tc) ; Sustain time (Ts) ; Relaxation time (Tr)
Delay time (Td) as a time between the electrical impulse and 10% of the contraction; Contraction time (Tc) as a time between 10% and 90% of the contraction; Sustain time (Ts) as a time between 50% of the contraction and 50% of the relaxation; Relaxation time (Tr) as a time between 90% and 50% of the relaxation.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BandagesStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Garcia, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735408
- Sponsor's protocol ID
- P2015/35RM
- Status last verified
- Apr 2016
- First submitted
- 18 Dec 2015
- Last updated
- 12 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tensiomyography Effects of the Kinesiotape Tension in the Muscular Stiffness of the Low Back Region
- ClinicalTrials.gov ID
- NCT02735408
- Acronym / sponsor ID
- P2015/35RM
- Conditions
- Bandages, Muscle Tonus, Low Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 12 Apr 2016 (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.
Lumbar pain is a quite prevalent pathology in general population within general and sporting population, which comes to mean high sanitary and sport costs. This concrete pain´s nature is often unspecific, but it seems that one of the main risk factors that predispose to suffer from it are changes in the paravertebral-lumbar musculature stiffness.
Since one decade approximately, it has proliferated, especially within sportsmen and women the use of a therapeutic technique: the neuromuscular bandage best known as Kinesiotape (KT). This treatment seems to accept different applications, despite there´s still a lack of scientific evidence for several of its supposed effects. One of the theories about its use technique is that the bandage strain generates different effects in musculature stiffness. Thus, when the bandage is applied over the skin with a pre-stretching of the elastic bandage, it can cause arise of stiffness and strength muscle empowerment. On the other hand, if the bandage is applied without strain, the opposite result would appear, relaxation and strength muscle decrease.
For trainers and therapists is important to know if the KT effect differs over the bandage technique, since the application could be different according to the specific troubles reported by the athletes. For example, talking about cyclists, who keep constantly a hold rachis lumbar flexion, could be interesting to normalize the lumbar musculature stiffness, by placing the bandage with certain strain to achieve a mechanic effect. Nevertheless, talking about other sports like weightlifting, the bandage effect should be the stiffness arisen as a preventive measure, for avoiding injuries derived from the lack of motor control in the lumbar region. These lumbar-region muscle problems affect to popular and majority sports like football, so lumbar pain is very frequently reported by football players, normally due to an agonist-antagonist musculature unbalance. In all these terms, the use of KT would be interesting in order to reduce the musculature strain degree.
Tensiomyography (TMG) is showing as one of the most useful and reliable instrument for the musculature stiffness assessing, due to its velocity, harmlessness, sensing and high reproducibility. Taking in consideration that the maximum deformity measured by the TMG is inversely related with the muscle stiffness, and whereas this project pretends to modify that stiffness by means of the KT application, it seems obvious that TMG is the most suitable measurement instrument.
All these precedents considered, the present project pretends to analyze the effects of different KT strain application along 48 hours with strains techniques of 100%, strain 50% and strain 0% in the normalization of the paravertebral-lumbar musculature stiffness, by means of TMG monitoring.
Detailed description
Lumbar pain is a quite prevalent pathology in general population within general and sporting population, which comes to mean high sanitary and sport costs. This concrete pain´s nature is often unspecific, but it seems that one of the main risk factors that predispose to suffer from it are changes in the paravertebral-lumbar musculature stiffness.
Since one decade approximately, it has proliferated, especially within sportsmen and women the use of a therapeutic technique: the neuromuscular bandage best known as Kinesiotape (KT). This treatment seems to accept different applications, despite there´s still a lack of scientific evidence for several of its supposed effects. One of the theories about its use technique is that the bandage strain generates different effects in musculature stiffness. Thus, when the bandage is applied over the skin with a pre-stretching of the elastic bandage, it can cause arise of stiffness and strength muscle empowerment. On the other hand, if the bandage is applied without strain, the opposite result would appear, relaxation and strength muscle decrease.
For trainers and therapists is important to know if the KT effect differs over the bandage technique, since the application could be different according to the specific troubles reported by the athletes. For example, talking about cyclists, who keep constantly a hold rachis lumbar flexion, could be interesting to normalize the lumbar musculature stiffness, by placing the bandage with certain strain to achieve a mechanic effect. Nevertheless, talking about other sports like weightlifting, the bandage effect should be the stiffness arisen as a preventive measure, for avoiding injuries derived from the lack of motor control in the lumbar region. These lumbar-region muscle problems affect to popular and majority sports like football, so lumbar pain is very frequently reported by football players, normally due to an agonist-antagonist musculature unbalance. In all these terms, the use of KT would be interesting in order to reduce the musculature strain degree.
Tensiomyography (TMG) is showing as one of the most useful and reliable instrument for the musculature stiffness assessing, due to its velocity, harmlessness, sensing and high reproducibility. Taking in consideration that the maximum deformity measured by the TMG is inversely related with the muscle stiffness, and whereas this project pretends to modify that stiffness by means of the KT application, it seems obvious that TMG is the most suitable measurement instrument.
All these precedents considered, the present project pretends to analyze the effects of different KT strain application along 48 hours with strains techniques of 100%, strain 50% and strain 0% in the normalization of the paravertebral-lumbar musculature stiffness, by means of TMG monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100% KT Tension | Experimental | Other: Kinesiotape (KT)100% KT Tension |
| 50% KT Tension | Experimental | Other: Kinesiotape (KT)50% KT Tension |
| 0% KT Tension | Experimental | Other: Kinesiotape (KT)0% KT Tension |
| Control (Without KT) | No intervention | –Control (Without KT) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjets without exclusion criteria
- Workers from UEM
Key exclusion criteria (1 listed)
- Low back conditions
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 |
|---|---|---|
| Kinesiotape (KT) | Other | 0% KT Tension, 100% KT Tension, 50% KT Tension |
Primary outcome
Tensiomyography changes (seconds): Delay time (Td) ; Contraction time (Tc) ; Sustain time (Ts) ; Relaxation time (Tr)
Time frame: 4 Weeks
Delay time (Td) as a time between the electrical impulse and 10% of the contraction; Contraction time (Tc) as a time between 10% and 90% of the contraction; Sustain time (Ts) as a time between 50% of the contraction and 50% of the relaxation; Relaxation time (Tr) as a time between 90% and 50% of the relaxation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
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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.
Mónica García, PT,MSc contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kinesiotape (KT) in people with Bandages and Muscle Tonus, run by Universidad Europea de Madrid at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mónica García, PT,MSc (monica.garcia.ftp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tensiomyography changes (seconds): Delay time (Td) ; Contraction time (Tc) ; Sustain time (Ts) ; Relaxation time (Tr) (time frame: 4 Weeks). 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 12 Apr 2016.