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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02735408
Other study ID # P2015/35RM
Secondary ID
Status Recruiting
Phase Phase 1
First received December 18, 2015
Last updated April 6, 2016
Start date October 2015
Est. completion date September 2016

Study information

Verified date April 2016
Source Universidad Europea de Madrid
Contact Mónica García, PT,MSc
Email monica.garcia.ftp@gmail.com
Is FDA regulated No
Health authority SPAIN: European University Review Board
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- Subjets without exclusion criteria

- Workers from UEM

Exclusion Criteria:

- Low back conditions

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Kinesiotape (KT)


Locations

Country Name City State
Spain Universidad Europea Madrid
Spain Universidad Europea Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 Weeks Yes
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