NCT03866070

Brief Summary

Introduction: Handball is a sport with a high prevalence of shoulder injuries due to the overuse that causes a glenohumeral internal rotation deficit, and excess of external rotation and scapular dyskinesia. Stretching is essential to restore physiological movement and improve strength. Aim: To evaluate the efficacy of a posterior capsule stretching and strengthening of the shoulder and scapular program in handball players from 18 to 37 years old. Study design: randomized clinical trial, multicenter, single-blind with follow-up period. Methods: 60 handball players will be randomly assigned to the two study groups (experimental and control). The intervention will last 4 weeks, with 3 weekly sessions with a duration of 21 and 12 minutes each. The study variables will be: range of motion in internal and external rotation (goniometer), throwing speed (Ball Throwing Speed Test), functionality (DASH questionnaire), perceived exertion (Borg scale), glenohumeral stability (CKCUEST y YBT-UQ Test) and the throwing force (Overhead Medicine Ball Throw). The intervention will consist in the application of stretching of the posterior shoulder capsule with an exercise protocol. A Kolmogorov-Smirnov analysis will calculate the normality of the distribution. In case of homogeneity of the groups, with the t-student test of repeated measurements and an ANOVA of repeated averages, the difference between the different evaluations and the intra- and inter-subject effect will be calculated. Expected results: Improved range of motion of the shoulder, strength and throwing speed after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 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 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 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

HandballPhysiotherapyShoulder instabilityScapular dyskinesiaFemale

Outcome Measures

Primary Outcomes (1)

  • Change from baseline functionality of the shoulder after treatment and at month

    The functionality of the shoulder will be measured with the questionnaire Disability of the Arm, Shoulder and Hand (DASH). This scale consists of 30 items (of functionality). The score range of this scale ranges from 0 to 100 points (where a higher score indicates less functionality).

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

Secondary Outcomes (6)

  • 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 launch speed after treatment and at month

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

  • Change from baseline shoulder stability after treatment and at month

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

  • Change from baseline distance range after treatment and at month

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

  • Change from baseline strength of upper limbs after treatment and at month

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

  • +1 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

The subjects that are part of the experimental group will carry out the intervention thought the performance of strengthening exercises of the shoulder and scapula, and capsular stretches.

Other: Experimental

Control

ACTIVE COMPARATOR

Subjects that are part of the control group will perform shoulder strengthening exercises exclusively.

Other: Control

Interventions

Two exercises will be done to strengthen the external rotation (using elastic bands): standing with 90 degrees of shoulder abduction and elbow flexion and also in standing with the shoulder in neutral position and the elbow flexed to 90 degrees. Subjects will perform 3 sets of 10 repetitions with the band slightly stretched, at a distance of 0.70 m from the wall. Dumbbell exercises will be performed through 4 exercises: flexion in the horizontal plane of 135º, external rotation in lateral decubitus, horizontal abduction with external rotation, and extension in prone position. There will be 5 repetitions each exercise of 3 seconds each, with 2 minutes of rest between exercises.

Also known as: Strengthening exercises and capsular stretches
Experimental
ControlOTHER

Two exercises will be done to strengthen the external rotation, using elastic bands. The first, standing, with 90 degrees of shoulder abduction and elbow flexion. The second, also in standing, with the shoulder in neutral position and the elbow flexed to 90 degrees. Subjects will perform 3 sets of 10 repetitions with the band slightly stretched, at a distance of 0.70 m from the wall. The band will be subject to a surface, at an equal distance from the subject's elbow to the ground. The repetitions will last one second in concentric external rotation and two seconds in eccentric external rotation, with a rest of 30 seconds between series.

Also known as: Strengthening exercises
Control

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Handball players federated in the Madrid Handball Federation
  • With an age range between 18 and 37 years
  • More than 2 years of handball sports
  • Currently participate in amateur competitions of First National Women's category.

You may not qualify if:

  • Have suffered a shoulder injury in the last six months
  • Who are currently doing some physiotherapy treatment
  • Who fail to participate in the established intervention and evaluation sessions
  • Refusing to 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

Shoulder InjuriesDisease

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological 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 8, 2019

Primary Completion

April 10, 2019

Study Completion

June 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations