NCT02735408

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

December 18, 2015

Last Update Submit

April 6, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

100% KT Tension

EXPERIMENTAL

100% KT Tension

Other: Kinesiotape (KT)

50% KT Tension

EXPERIMENTAL

50% KT Tension

Other: Kinesiotape (KT)

0% KT Tension

EXPERIMENTAL

0% KT Tension

Other: Kinesiotape (KT)

Control (Without KT)

NO INTERVENTION

Control (Without KT)

Interventions

0% KT Tension100% KT Tension50% KT Tension

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Workers from UEM
  • Low back conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad Europea

Madrid, Madrid, Spain

RECRUITING

Universidad Europea

Madrid, Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Central Study Contacts

Mónica García, PT,MSc

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc,PT

Study Record Dates

First Submitted

December 18, 2015

First Posted

April 12, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations