Instrument-assisted Soft Tissue Mobilization to Improve Mobility and Hip Strength in Semi-professional Rugby Players

September 1, 2021 updated by: Investigación en Hemofilia y Fisioterapia

Efficacy of a Physiotherapy Intervention Through the Mobilization of Soft Tissues Assisted by Instruments in the Improvement of Mobility and Hip Strength in Semi-professional Rugby Players. A Randomized Clinical Study

Instrument-assisted soft tissue mobilization is a method that uses different devices to approach the myofascial system in variables such as joint mobility and muscle strength.

The objective of the study is to assess the effectiveness of the technique of soft tissue mobilization assisted by instruments in increasing the mobility of hip abduction and strength of the hip adductor musculature, in semi-professional rugby players federated in Spain of 18 at 32 years old Randomized, simple blind clinical study. 29 rugby players will be randomized to the two study groups: experimental (assisted soft tissue mobilization in the adductor leg muscles) and control (without intervention). The intervention will last 4 weeks, with 1 session per week, approximately 1 or 2 minutes each. The study variables will be hip abduction mobility (goniometry) and the strength of the hip adductor musculature (sphygmomanometry). A descriptive statistical analysis will be carried out calculating the main statistical characteristics. The distribution of normality will be calculated through an analysis of Saphiro Wilk. With the t-student test of repeated measures the differences will be calculated after the evaluations, and through an ANOVA of repeated measures the intra and intersubject effect will be calculated. The effect size will be calculated using the Cohen mean difference formula It is expected to observe an increase in hip abduction, as well as an increase in the strength of the adductor musculature of the hip.

Study Overview

Status

Withdrawn

Conditions

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Comunity Of Madrid
      • Madrid, Comunity Of Madrid, Spain, 28670
        • Universidad Europea de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 32 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male rugby players
  • With an age range of 18 to 32 years
  • Semi-professionals federated in Spain (category Division of Honor B, group C)
  • Who have not had previous injuries to the lower limb in the last 2 months.

Exclusion Criteria:

  • Subjects who: present any type of sensory alteration in the skin
  • Are taking muscle relaxants
  • Have skin infections
  • Are allergic to the material of the intervention or evaluation tool
  • Have not signed the informed consent document.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental group
Each session will last 1 or 2 minutes, with one intervention being carried out a week, over a period of 4 weeks. Prior to the start of training, the instrument-assisted soft tissue mobilization technique will be performed
It will be done for 60 seconds, making a total of 30 strokes with the tool in the longitudinal direction to the muscle fibers. The physiotherapist will previously apply some massage cream to the area to be treated (adductor musculature) so that the tool slides at a 45º angle. Landslides will be made from the femoral condyle to the groin, and vice versa, exerting a pressure with the instrument of 3 over 10 on the analog visual scale that the subject feels
Other Names:
  • Experimental group
NO_INTERVENTION: Control group
Players included in the control group will follow their usual training routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline range of motion of hip abduction after treatment and at month
Time Frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
A long arm goniometer will be used, following the protocol described by Nussbaumer et al. . Before collecting the data, participants will perform a 5-minute warm-up on an exercise bike. The athlete will be placed supine, attached to the stretcher with a pelvic girth, with the contralateral leg hanging by the edge of the stretcher. The fixed arm of the goniometer will be placed on the transverse line formed by the superior antero iliac spines and the mobile arm on the longitudinal axis of the thigh, matching the goniometer fulcrum with the superior anterior iliac iliac spine of the lower limb to be evaluated. With the help of another physiotherapist, a passive and complete hip abduction will be performed, and the evaluator, in charge of the goniometer, will take the measurement resulting from the test.
Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline strength of the hip adductor muscle after treatment and at month
Time Frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
It will be assessed with a sphygmomanometer. The unit of measure will be millimeters of mercury (mmHg). The athlete will be placed in lateral recumbency with the leg to be evaluated extended and in contact with the stretcher and the contralateral leg at 90º of hip and knee flexion. The athlete will grab with his upper hand to the side of the stretcher and on his lower arm will support his head. The evaluator will place the pressure cuff (folded in thirds and preinflated to 10 mmHg) 5 cm proximally over the medial malleolus and secure it with a cinch that surrounds the stretcher. The athlete will exert a maximum isometric force against the pressure cuff and the webbing for 5 seconds. The test will be repeated 4 times, with a 30 second rest period between repetitions. The highest value of the 4 measurements will be chosen. A higher sphygmomanometer score will indicate greater strength of the hip adductor musculature (25,27).
Screening visit, within the first seven days after treatment and after one month follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 2, 2020

Primary Completion (ACTUAL)

May 20, 2020

Study Completion (ACTUAL)

June 10, 2020

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (ACTUAL)

February 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rugby Player

Clinical Trials on Assisted soft tissue mobilization

3
Subscribe