Low Back PainNCT03865784
Kinesiotape and Core Exercises in Federated Boxers
A study testing Experimental in people with Low Back Pain, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2019to 20 Jun 2019
- Phase
- Interventional
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Low Back Pain
- Being tested
- Experimental, Control
- Keywords
- Boxing, Injuries, Physiotherapy, Kinesiotape, Core, Low back pain
- Medical subject headings
- Low Back Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
The intervention through Core exercises will consist in the application of a protocol of four Core stabilization exercises. This protocol will consist of the following exercises: abdominal plate, bilateral plate, hunting dog and gluteal bridge. The intervention by Kinesiotape will be performed with the subject in a sitting position with both arms relaxed throughout the body, while the physiotherapist will place the bases of the strips without tension, on the sacroiliac joint. Once this is done, proceed to ask the subject to lean forward applying the rest of the strip, except the distal edge, with a tension of between 15 and 25%, finally requesting the subject to rejoin straining the distal base without tension, on the twelfth dorsal spinous process.
ControlOther
The intervention through Core exercises will consist in the application of a protocol of four Core stabilization exercises. The objective of the application of the technique based on this type of exercise is to improve muscle strength, endurance and neuromuscular control. This protocol will consist of the following exercises: abdominal plate, bilateral plate, hunting dog and gluteal bridge. The intervention by Kinesiotape will be performed with the subject in a sitting position with both arms relaxed throughout the body, while the physiotherapist will place the bases of the strips without tension, on the sacroiliac joint. Once this is done the tape will be placed without tension and sn movement of the subject.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Each session will be held in a group and will last 35 minutes, taking place 2 sessions a week, in a period of 4 weeks. The intervention will be carried out at the end of the training session and after drying the sweat of the area to be treated. After the training, the Core and Kinesiotape exercises with tension and stretching will be performed Receives: Other: Experimental |
| Control | Active comparator | Each session will be held in a group and will last 35 minutes, taking place 2 sessions a week, in a period of 4 weeks. The intervention will be carried out at the end of the training session and after drying the sweat of the area to be treated. After the training, the Core and Kinesiotape exercises technique will be performed without tension or stretching Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (5)
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.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
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.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
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.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
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.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
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.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start12 Mar 2019
- Primary completion20 Apr 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865784
- Sponsor's protocol ID
- COREKT
- Status last verified
- Jan 2020
- First submitted
- 4 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03865784
- Acronym / sponsor ID
- COREKT
- Conditions
- Low Back Pain
- Keywords
- Boxing, Injuries, Physiotherapy, Kinesiotape, Core, Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 7 Mar 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: ExperimentalEach session will be held in a group and will last 35 minutes, taking place 2 sessions a week, in a period of 4 weeks. The intervention will be carried out at the end of the training session and after drying the sweat of the area to be treated. After the training, the Core and Kinesiotape exercises with tension and stretching will be performed |
| Control | Active comparator | Other: ControlEach session will be held in a group and will last 35 minutes, taking place 2 sessions a week, in a period of 4 weeks. The intervention will be carried out at the end of the training session and after drying the sweat of the area to be treated. After the training, the Core and Kinesiotape exercises technique will be performed without tension or stretching |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| ExperimentalThe intervention through Core exercises will consist in the application of a protocol of four Core stabilization exercises. This protocol will consist of the following exercises: abdominal plate, bilateral plate, hunting dog and gluteal bridge. The intervention by Kinesiotape will be performed with the subject in a sitting position with both arms relaxed throughout the body, while the physiotherapist will place the bases of the strips without tension, on the sacroiliac joint. Once this is done, proceed to ask the subject to lean forward applying the rest of the strip, except the distal edge, with a tension of between 15 and 25%, finally requesting the subject to rejoin straining the distal base without tension, on the twelfth dorsal spinous process. | Other | Experimental |
| ControlThe intervention through Core exercises will consist in the application of a protocol of four Core stabilization exercises. The objective of the application of the technique based on this type of exercise is to improve muscle strength, endurance and neuromuscular control. This protocol will consist of the following exercises: abdominal plate, bilateral plate, hunting dog and gluteal bridge. The intervention by Kinesiotape will be performed with the subject in a sitting position with both arms relaxed throughout the body, while the physiotherapist will place the bases of the strips without tension, on the sacroiliac joint. Once this is done the tape will be placed without tension and sn movement of the subject. | Other | Control |
Primary outcome
Change from baseline pain perception after treatment and at month: VAS
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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
5 secondary outcomes
Change from baseline pain perception at the pressure after treatment and at month: pressure algometer
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline perception of effort after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline trunk flexion after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline trunk flexion after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline resistance of the lumbar extensor musculature after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Low Back Pain, run by Investigación en Hemofilia y Fisioterapia at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain perception after treatment and at month: VAS (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 27 Jan 2020.