NCT03865784

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

March 4, 2019

Last Update Submit

January 23, 2020

Conditions

Keywords

BoxingInjuriesPhysiotherapyKinesiotapeCoreLow back pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change from baseline pain perception at the pressure after treatment and at month: pressure algometer

    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

    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

    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

    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

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

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

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

Other: Control

Interventions

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.

Experimental
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.

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Low Back PainWounds and Injuries

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 7, 2019

Study Start

March 12, 2019

Primary Completion

April 20, 2019

Study Completion

June 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations