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Electrotherapy and Myofascial Therapy in Padel Players

Primary Purpose

Low Back Pain, Mechanical

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Myofascial
Electrotherapy
Sponsored by
Investigación en Hemofilia y Fisioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Back Pain, Mechanical focused on measuring Paddle-tennis, Myofascial release, Electrotherapy, Physiotherapy, Low back, Randomized clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Padel players
  • With federal sheet
  • Male
  • Over 18 years
  • Currently participate in regional and / or national competitions

Exclusion Criteria:

  • Present a medical diagnosis of musculoskeletal pathology
  • Not signed the informed consent document.

Sites / Locations

  • Universidad Europea de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myofascial

Electrotherapy

Arm Description

The subjects that include the experimental group will receive an intervention through myofascial therapy of crossed hands and electrotherapy

The subjects that are included in the experimental group will receive an intervention through electrotherapy

Outcomes

Primary Outcome Measures

Change from baseline low back flexion after treatment and at a month
Low back flexion will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to bend to the maximum, keeping the knees extended. When the maximum flexion is reached, the increase in the distance between the skin marks will be measured. The unit of measurement is the centimeter (the greater the distance, the greater the mobility in the flexion of the lumbar spine).

Secondary Outcome Measures

Change from baseline low back extension after treatment and at a month
Low back extension will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to lean back to the maximum, keeping the knees extended. When the maximum extension is reached, the decrease in the distance between the skin marks will be measured. The unit of measurement is the centimeter (at a lower distance, greater mobility in extension of the lumbar spine).
Change from baseline low back flexion after treatment and at a month
Low back flexion will be measured with the Fingertip-to-floor test. With the subject standing on a platform 20 cm high (without shoes and with their feet together), you will be asked to lean towards flexion, while keeping your knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the platform shall be measured with a flexible measuring tape and expressed in centimeters. The vertical distance (measured in centimeters) between the platform and the tip of the middle finger will be positive when the subject does not reach the platform and negative when it can go further.

Full Information

First Posted
March 6, 2019
Last Updated
January 23, 2020
Sponsor
Investigación en Hemofilia y Fisioterapia
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1. Study Identification

Unique Protocol Identification Number
NCT03867292
Brief Title
Electrotherapy and Myofascial Therapy in Padel Players
Official Title
Efficacy of a Physiotherapy Intervention by Electrotherapy Combined With Myofascial Therapy for the Improvement of Lumbar Region Mobility in Federated Padel Players. A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2019 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Investigación en Hemofilia y Fisioterapia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction. The lumbar region is one of the locations with the highest incidence of injuries in the paddle players. The crossed hands myofascial technique is used to release the restrictions of the thoracolumbar fascia, improving its mobility. The electrotherapy technique of TENS consists in the application of a low frequency current for the recovery, capitalization and oxygenation of the muscle, thus improving mobility and pain. Aim. To evaluate the efficacy of an intervention by electrotherapy combined with myofascial therapy, in the lumbar region, for a mobility improvement in older paddle-tennis federated players. Study design. Randomized, multicenter, simple blind, clinical trial with follow-up period. Methods. 30 players paddle will be assigned to the two study groups: experimental (intervention through therapy myofascial and electrotherapy) and control (intervention by electrotherapy). The intervention will have a duration of 4 weeks, with 2 sessions per week, lasting 15 minutes. There will be three evaluations: pre-intervention, post-intervention and follow-up. The variable of study is the mobility of the lumbar spine in the movements of flexion and extension (assessed by the employment of tests of Schober and Fingertip-to-floor). The analysis of normality be performed with the Kolmogorov-Smirnof, and in case of homogeneity of the groups is used in parametric tests: test t-student for paired data (difference between the different assessments) and ANOVA of mean repeated (intra-and intersujeto). Expected results. Improvement of the mobility of the lumbar spine in the movements of flexion and extension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
Paddle-tennis, Myofascial release, Electrotherapy, Physiotherapy, Low back, Randomized clinical trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myofascial
Arm Type
Experimental
Arm Description
The subjects that include the experimental group will receive an intervention through myofascial therapy of crossed hands and electrotherapy
Arm Title
Electrotherapy
Arm Type
Active Comparator
Arm Description
The subjects that are included in the experimental group will receive an intervention through electrotherapy
Intervention Type
Other
Intervention Name(s)
Myofascial
Intervention Description
The aim of the application of the crossed hands technique is to produce a deep fascial release, placing the subject in prone position, while the standing physiotherapist will contact with one hand on the spine at the level of the thoracolumbar hinge and with the other hand on the sacrum, so that the hands are crisscrossed. The crossed hands technique will be performed between 90 seconds and 5 minutes. The application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally.
Intervention Type
Other
Intervention Name(s)
Electrotherapy
Intervention Description
The application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally.
Primary Outcome Measure Information:
Title
Change from baseline low back flexion after treatment and at a month
Description
Low back flexion will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to bend to the maximum, keeping the knees extended. When the maximum flexion is reached, the increase in the distance between the skin marks will be measured. The unit of measurement is the centimeter (the greater the distance, the greater the mobility in the flexion of the lumbar spine).
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary Outcome Measure Information:
Title
Change from baseline low back extension after treatment and at a month
Description
Low back extension will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to lean back to the maximum, keeping the knees extended. When the maximum extension is reached, the decrease in the distance between the skin marks will be measured. The unit of measurement is the centimeter (at a lower distance, greater mobility in extension of the lumbar spine).
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline low back flexion after treatment and at a month
Description
Low back flexion will be measured with the Fingertip-to-floor test. With the subject standing on a platform 20 cm high (without shoes and with their feet together), you will be asked to lean towards flexion, while keeping your knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the platform shall be measured with a flexible measuring tape and expressed in centimeters. The vertical distance (measured in centimeters) between the platform and the tip of the middle finger will be positive when the subject does not reach the platform and negative when it can go further.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Padel players With federal sheet Male Over 18 years Currently participate in regional and / or national competitions Exclusion Criteria: Present a medical diagnosis of musculoskeletal pathology Not signed the informed consent document.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Cuesta-Barriuso, PhD
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Europea de Madrid
City
Madrid
State/Province
Comunity Of Madrid
ZIP/Postal Code
28670
Country
Spain

12. IPD Sharing Statement

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Electrotherapy and Myofascial Therapy in Padel Players

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