NCT03867292

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

March 10, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 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 6, 2019

Last Update Submit

January 23, 2020

Conditions

Keywords

Paddle-tennisMyofascial releaseElectrotherapyPhysiotherapyLow backRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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).

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

Secondary Outcomes (2)

  • Change from baseline low back extension after treatment and at a month

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

  • Change from baseline low back flexion after treatment and at a month

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

Study Arms (2)

Myofascial

EXPERIMENTAL

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

Other: Myofascial

Electrotherapy

ACTIVE COMPARATOR

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

Other: Electrotherapy

Interventions

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.

Myofascial

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.

Electrotherapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Present a medical diagnosis of musculoskeletal pathology
  • Not signed 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 Pain

Interventions

Myofascial Release TherapyElectric Stimulation Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

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 6, 2019

First Posted

March 7, 2019

Study Start

March 10, 2019

Primary Completion

April 15, 2019

Study Completion

June 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations