Shoulder Injuries and DisordersNCT03866070
Stretching the Posterior Capsule of the Shoulder in the Stability and the Throwing Performance in Handball Players
A study testing Experimental in people with Shoulder Injuries and Disorders, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shoulder Injuries and Disorders
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 8 Mar 2019to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Physiotherapy Intervention by Stretching the Posterior Capsule of the Shoulder in the Stability of the Glenohumeral Joint and the Throwing Performance in Handball Players. A Randomized Clinical Trial
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.
Read more
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.
- Conditions
- Shoulder Injuries and Disorders
- Being tested
- Experimental, Control
- Keywords
- Handball, Physiotherapy, Shoulder instability, Scapular dyskinesia, Female
- Medical subject headings
- Shoulder Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Strengthening exercises and capsular stretches
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.
ControlOther
Also called Strengthening exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Experimental |
| Control | Active comparator | Subjects that are part of the control group will perform shoulder strengthening exercises exclusively. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
The perception of effort will be measured with the modified Borg scale. In this instrument, 11 items are evaluated, with a score of 0 to 10 points, where 0 equals the minimum effort and 10 the maximum that they can perform.
Measured: 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
The launch speed with the handball (56 cm and 375 grams of weight) will be measured using the Ball Throwing Speed Test. This measuring instrument requires the use of a stopwatch. The measurement will be made through the execution of 6 launches. The athletes must have both feet resting on the ground at a distance of 2.5 meters from the wall, making the throws at maximum speed, collecting the best result. The unit of measurement of this test is meters / second (where the higher the score, the faster the launch).
Measured: 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
The assessment of shoulder stability will be carried out using the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST). The player will be placed in the ironing position with the arms extended and supported on the ground. The objective is to assess how many times it is able to raise the arm to touch the opposite shoulder in 15 seconds. This test is measured by the number of repetitions you perform (the greater the number of repetitions, the better the stability of the shoulder).
Measured: 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
Distance range will be calculated using the Upper Quarter Y-Balance Test (YBT-UQ Test). We will use 3 different angles from where the handball players, with a support arm, should push an object on a tape measure. This test measures the stability and mobility of the upper limbs of the body. The unit of measurement for this test is centimeters (the greater the distance traveled in cm, the better the reach distance of the upper limbs).
Measured: 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
The strength of upper limbs will be evaluated with Overhead Medicine Ball Throw (OMBT). The athletes, with both feet resting on the ground and using a reference point "0" of the tape measure, will throw a medicine ball over the head in order to reach the greatest possible distance. This distance will be measured with a tape measure, the meter being the unit of measurement the centimeter (the greater the distance, the greater the strength of the upper limbs)
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline shoulder range of motion after treatment and at month
The measurement of the range of movement of the shoulder will be made with a universal goniometer. The movements of external and internal rotation will be measured. The women will be in the supine position with the scapula and the spine stabilized. The goniometer axis will be placed in the olecranon, while the fixed arm will be located vertical to the axis of the humerus, and the mobile arm parallel to the forearm by the ulna axis. The unit of measurement will be in degrees, with the normal range of mobility being 70 to 90 degrees in internal and external rotation, respectively.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start8 Mar 2019
- Primary completion10 Apr 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866070
- Sponsor's protocol ID
- ECEF
- Status last verified
- Jan 2020
- First submitted
- 4 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Intervention by Stretching the Posterior Capsule of the Shoulder in the Stability of the Glenohumeral Joint and the Throwing Performance in Handball Players. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03866070
- Acronym / sponsor ID
- ECEF
- Conditions
- Shoulder Injuries and Disorders
- Keywords
- Handball, Physiotherapy, Shoulder instability, Scapular dyskinesia, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: ExperimentalThe 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. |
| Control | Active comparator | Other: ControlSubjects that are part of the control group will perform shoulder strengthening exercises exclusively. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalAlso: Strengthening exercises and capsular stretchesTwo 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. | Other | Experimental |
| ControlAlso: Strengthening exercisesTwo 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. | Other | Control |
Primary outcome
Change from baseline functionality of the shoulder after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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).
6 secondary outcomes
Change from baseline perception of effort after treatment and at month
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline shoulder range of motion after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Shoulder Injuries and Disorders, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline functionality of the shoulder after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.