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Kinesiotape Tensiomyography in Low Back Region

Primary Purpose

Bandages, Muscle Tonus, Low Back Pain

Status
Unknown status
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Kinesiotape (KT)
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bandages

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjets without exclusion criteria
  • Workers from UEM

Exclusion Criteria:

  • Low back conditions

Sites / Locations

  • Universidad EuropeaRecruiting
  • Universidad EuropeaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

100% KT Tension

50% KT Tension

0% KT Tension

Control (Without KT)

Arm Description

100% KT Tension

50% KT Tension

0% KT Tension

Control (Without KT)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2015
Last Updated
April 6, 2016
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02735408
Brief Title
Kinesiotape Tensiomyography in Low Back Region
Official Title
Tensiomyography Effects of the Kinesiotape Tension in the Muscular Stiffness of the Low Back Region
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bandages, Muscle Tonus, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
100% KT Tension
Arm Type
Experimental
Arm Description
100% KT Tension
Arm Title
50% KT Tension
Arm Type
Experimental
Arm Description
50% KT Tension
Arm Title
0% KT Tension
Arm Type
Experimental
Arm Description
0% KT Tension
Arm Title
Control (Without KT)
Arm Type
No Intervention
Arm Description
Control (Without KT)
Intervention Type
Other
Intervention Name(s)
Kinesiotape (KT)
Primary Outcome Measure Information:
Title
Tensiomyography changes (seconds): Delay time (Td) ; Contraction time (Tc) ; Sustain time (Ts) ; Relaxation time (Tr)
Description
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.
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjets without exclusion criteria Workers from UEM Exclusion Criteria: Low back conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mónica García, PT,MSc
Email
monica.garcia.ftp@gmail.com
Facility Information:
Facility Name
Universidad Europea
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mónica García, PT, MSc
Email
monica.garcia@universidadeuropea.es
Facility Name
Universidad Europea
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Móncia García, PT, MSc
Phone
620005953
Email
monica.garcia@universidadeuropea.es

12. IPD Sharing Statement

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Kinesiotape Tensiomyography in Low Back Region

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