Low Back Pain Clinical Trial
Official title:
Kinesiotape® and Core Exercises in the Improvement of Nonspecific Lumbar Pain, Trunk Flexion, Resistance of the Spinal Erector Musculature and Effort Perception in Federated Boxers
NCT number | NCT03865784 |
Other study ID # | COREKT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 12, 2019 |
Est. completion date | June 20, 2019 |
Verified date | January 2020 |
Source | Investigación en Hemofilia y Fisioterapia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction. Nonspecific lumbar pain is a very common cause of sports decline in boxers,
possibly due to the repetitive movements of flexion and rotation in their sport, so the
investigators believe it is interesting to seek an intervention that helps these athletes to
reduce their incidence.
Aim. To improve non-specific low back pain, range of motion of trunk flexion; the muscular
resistance of the spinal erectors and the subjective perception of the effort in federated
boxers older than 18 years.
Study design. Randomized, multicentric and double-blind clinical trial with follow-up period.
Methods. 60 federated boxers of legal age will be recruited, who will be randomly assigned to
the study groups: experimental (Core and Kinesiotape® exercises) and control (Core exercises
and Kinesiotape® tubes without tension). The intervention will last 4 weeks, with 2 weekly
sessions, lasting 35 minutes. Three evaluations will be carried out (pre-treatment,
post-treatment and follow-up) for the dependent variables. The analysis of normality will be
carried out with the Kolmogorov Smirnov test and in case of homogeneity of the sample, with
the t-student test of related samples and the ANOVA of repeated means, the difference between
the evaluations and the intra e effect will be calculated. intersubject, respectively.
Expected results. It is expected to observe the effectiveness of the Core and Kinesiotape®
exercises in the perception of nonspecific lumbar pain, the range of movement of trunk
flexion and lumbar resistance, and the perception of effort.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 20, 2019 |
Est. primary completion date | April 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Federated boxers - Over 18 years - Male - With non-specific back pain that does not incapacitate them for the realization of their sport or work activity. Exclusion Criteria: - Federated boxers with lumbar injury with medical diagnosis - Who are or have been treated by pharmacological or physiotherapy in the last 6 months - Presenting allergies or alterations of the skin - Not sign the informed consent document. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Europea de Madrid | Madrid | Comunity Of Madrid |
Lead Sponsor | Collaborator |
---|---|
Investigación en Hemofilia y Fisioterapia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline pain perception after treatment and at month: VAS | Pain perception measurement will be measured with the visual analogue scale, which is represented by a line from 0 mm to 100 mm indicating at the ends the states of `no pain '(0) and` as much pain as it can bear' (10) . The EVA scale is measured as the distance between the line of `no pain 'and that marked by the subject. A change greater than 13 mm between the two would be considered clinically relevant | Screening visit, within the first seven days after treatment and after one month follow-up visit | |
Secondary | Change from baseline pain perception at the pressure after treatment and at month: pressure algometer | The perception of pain at the pressure will be calculated with a pressure algometer (model Baselin de Quirumed), whose assessment varies from 0 to 10 kg. It consists of a rubber block of 1 cm2, performing the evaluation by applying pressure in the paravertebral area to the height of the 3rd and 4th lumbar spinous processes, with the subject in the prone position. The unit of measure is kg. the subject indicating the perception of pain by means of an acoustic signal (for example: "stop"). The greater the units of measurement (kg), the better the perception of the subject's pain. | Screening visit, within the first seven days after treatment and after one month follow-up visit | |
Secondary | Change from baseline perception of effort after treatment and at month | To measure the perception of effort, the Borg scale will be used. This measuring instrument is designed to linearly describe exercise intensity and heart rate. In the simplest version of this scale, the numbers from 0 to 10 are used. The number 0 indicates a non-existent perception of the effort, and the number 10 implies an extremely strong perception of the intensity of the effort. | Screening visit, within the first seven days after treatment and after one month follow-up visit | |
Secondary | Change from baseline trunk flexion after treatment and at month | The trunk flexion will be evaluated by applying the Schober test. A mark will be made at the lumbosacral junction, and two other marks on the skin (one at 10 cm above the lumbosacral junction and another at 5 cm below). The subjects should flex their trunk to the maximum without flexing the knees and at the same time measure the distance between the upper and lower marks. The unit of measurement of this test is in centimeters, where a higher score indicates a greater range of trunk movement in flexion. | Screening visit, within the first seven days after treatment and after one month follow-up visit | |
Secondary | Change from baseline trunk flexion after treatment and at month | The trunk flexion will be evaluated the finger-ground test. The subject will stand in an anthropometric box, and perform a trunk flexion with the extended legs stretching both arms towards the ground and facing the palms towards their legs. The subjects must maintain that position for two seconds until the measurement is taken. The unit of measurement of this test is in centimeters, where a higher score indicates a greater range of trunk movement in flexion. | Screening visit, within the first seven days after treatment and after one month follow-up visit | |
Secondary | Change from baseline resistance of the lumbar extensor musculature after treatment and at month | The resistance of the lumbar extensor musculature will be evaluated through the Biering Sorensen test. This test consists of placing the subject in a prone position with the lower limbs fixed to the stretcher and the upper part of the body extended from the hip to the head, towards the outside of the stretcher. You will be asked to hold the horizontal position with your arms crossed over your chest as long as possible. This test has by unit of measurement the time (in seconds), where at higher valuation, greater resistance of the extensor musculature. | Screening visit, within the first seven days after treatment and after one month follow-up visit |
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