NCT04286061

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 25, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

February 25, 2020

Last Update Submit

September 1, 2021

Conditions

Keywords

RugbyPubalgiaStrengthRange of motionInstrument-assisted soft tissue mobilization.

Outcome Measures

Primary Outcomes (1)

  • Change from baseline range of motion of hip abduction after treatment and at month

    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 Outcomes (1)

  • Change from baseline strength of the hip adductor muscle 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 group

EXPERIMENTAL

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

Other: Assisted soft tissue mobilization

Control group

NO INTERVENTION

Players included in the control group will follow their usual training routine.

Interventions

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

Also known as: Experimental group
Experimental group

Eligibility Criteria

Age18 Years - 32 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location
0

Study Design

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

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 26, 2020

Study Start

March 2, 2020

Primary Completion

May 20, 2020

Study Completion

June 10, 2020

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations