Shoulder PainNCT02852707
Physical Performance and 3D Shoulder Kinematics of Asymptomatic Unilateral/Bilateral Overhead Athletes and Non-athletes
An observational study of Shoulder Pain, run by Universidade do Porto at 3 sites in Portugal.
Trial summary
This study compares the performance and 3-dimensional shoulder kinematics between sides in unilateral overhead-throwers (volleyball attackers), bilateral overhead athletes (swimmers) and non-athletes during two physical performance measures of the upper extremity, one in an open kinetic chain position (unilateral… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Chronic exposure to unilateral overhead sports activity, Chronic exposure to bilateral overhead sports activity and Not exposed
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 3 sitesPortugal
- Study dates
- 1 Jun 2018to Jul 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Athletes from sports organizations involved in competitive events and non-athletes from the general community/scholarly community
Who may be able to join
- Perform at least 150 degrees of arm elevation
Who cannot join
- history of shoulder dislocation
- surgery in the upper extremity ≥ 6 months
- injury in the past month
- evident abnormalities in posture and movement of the upper body quadrant
- pain at the time of testing
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Escola Superior de Saúde, Instituto Politécnico de Leiria
Leiria, 2411-901
Faculdade de Motricidade Humana, Universidade de Lisboa
Oeiras, Cruz-Quebrada, 1499-002
Faculdade de Desporto, Universidade do Porto
Porto, 4200-450
About this study
This study compares the performance and 3-dimensional shoulder kinematics between sides in unilateral overhead-throwers (volleyball attackers), bilateral overhead athletes (swimmers) and non-athletes during two physical performance measures of the upper extremity, one in an open kinetic chain position (unilateral seated shot put test) and the other in a closed kinetic chain position (upper quarter Y balance test)
Read the detailed description
3-dimensional shoulder kinematics (e.g., scapular angular position/displacement) at key events of each test will be described and compared across sides and groups. For the unilateral seated shot put test, the events are based on humeral motion: a) initiation of humeral motion, b) maximal humeral flexion, c) end of humeral motion. For the upper quarter Y balance test the events are the a) initiation of free hand motion on "GO", b) maximal reach on the medial direction, c) maximal reach on superolateral direction, and d) maximal reach on the inferolateral direction (kinematics measured on the stance upper extremity). The best of 3 maximal-effort trials on each side will be used for analysis. Warm-up exercises and two submaximal practice trials will be performed for preparation for maximal efforts and familiarization with the tests. A rest period of at least one minute between trials will be given to guarantee good physiological conditions to maximally perform. Further resting time will be allowed, if necessary, upon request of the participant.
- Conditions
- Shoulder Pain
- Being tested
- Chronic exposure to unilateral overhead sports activity, Chronic exposure to bilateral overhead sports activity, Not exposed
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic exposure to unilateral overhead sports activityBehavioural
Overhead sports athletes that have been chronically exposed (≥ 2 years) predominantly to specific unilateral overhead movement patterns of the dominant extremity ("throwing arm"), such as throwing or hitting a ball ("asymmetrical overhead sports).
Chronic exposure to bilateral overhead sports activityBehavioural
Overhead sports athletes that have been chronically exposed (≥ 2 years) predominantly to bilateral overhead movement patterns of the upper extremities, such as swimmers ("symmetrical overhead sports").
Not exposedBehavioural
People not engaged in regular sports competition/exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral overhead throwing athletes | Volleyball attackers involved in competitive events ≥ 2 years, ≥18 years of age Receives: Behavioral: Chronic exposure to unilateral overhead sports activity | |
| Bilateral overhead athletes | Swimmers involved in competitive events ≥ 2 years, ≥18 years of age Receives: Behavioral: Chronic exposure to bilateral overhead sports activity | |
| Non-athletes | Persons not regularly involved in sports activities or occupational overhead tasks (e.g. construction workers), ≥18 years of age Receives: Behavioral: Not exposed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side-to-side differences in the unilateral seated shot put test (normalized distance thrown, in centimeters)
The unilateral seated shot put test consists of pushing (not throwing) at shoulder height a ~3kg medicine ball as far and forward as possible while keeping the axial skeleton in contact with a wall, knees bent at a right angle, feet flat on the floor, and the non-testing arm resting on the lap.
Measured: Through study completion, an average of 1 year
Side-to-side differences in the upper quarter Y balance test (normalized maximal distance reached in each direction, in centimeters)
The upper quarter Y balance test is performed through the assistance of a testing device (Y-Balance Test Kit), with the subject stabilizing his/her body weight with the upper extremity being tested while performing maximal reaching efforts with the free hand in three directions: medial, superolateral, and inferolateral.
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Side-to-side differences in 3-dimensional scapular angular displacement (in degrees)
The angular displacement of the scapula in the 3 planes of orientation: lateral/medial (upward/downward) rotation, protraction/retraction (internal/external rotation), anterior/posterior tilting.
Measured: Through study completion, an average of 1 year
Side-to-side differences in 3-dimensional humerus angular displacement (in degrees)
The angular displacement of the humerus in the 3 planes of orientation: plane of elevation, elevation/depression, axial rotation.
Measured: Through study completion, an average of 1 year
Side-to-side differences in 3-dimensional thoracic angular displacement (in degrees)
The angular displacement of the thorax in the 3 planes of orientation: flexion/extension, lateral rotation (inclination), axial rotation.
Measured: Through study completion, an average of 1 year
Side-to-side differences in the upper quarter Y balance test (total excursion, in centimeters)
total excursion = sum of the 3 normalized reach distances, in centimeters
Measured: Through study completion, an average of 1 year
Side-to-side differences in the upper quarter Y balance test (overall performance score, in centimeters)
overall performance or composite score = average score of the 3 normalized reach distances, in centimeters.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start1 Jun 2018
- Primary completionApr 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lisbon, Instituto Politécnico de Leiria
- Responsible party
- Principal investigator, Nuno Morais, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852707
- Sponsor's protocol ID
- FADEUP_PhDPT_NunoMorais_std#1
- Status last verified
- Jan 2021
- First submitted
- 22 Jul 2016
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Performance and 3D Shoulder Kinematics of Asymptomatic Unilateral/Bilateral Overhead Athletes and Non-athletes
- ClinicalTrials.gov ID
- NCT02852707
- Acronym / sponsor ID
- FADEUP_PhDPT_NunoMorais_std#1
- Conditions
- Shoulder Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- University of Lisbon, Instituto Politécnico de Leiria
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- 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.
This study compares the performance and 3-dimensional shoulder kinematics between sides in unilateral overhead-throwers (volleyball attackers), bilateral overhead athletes (swimmers) and non-athletes during two physical performance measures of the upper extremity, one in an open kinetic chain position (unilateral seated shot put test) and the other in a closed kinetic chain position (upper quarter Y balance test)
Detailed description
3-dimensional shoulder kinematics (e.g., scapular angular position/displacement) at key events of each test will be described and compared across sides and groups. For the unilateral seated shot put test, the events are based on humeral motion: a) initiation of humeral motion, b) maximal humeral flexion, c) end of humeral motion. For the upper quarter Y balance test the events are the a) initiation of free hand motion on "GO", b) maximal reach on the medial direction, c) maximal reach on superolateral direction, and d) maximal reach on the inferolateral direction (kinematics measured on the stance upper extremity). The best of 3 maximal-effort trials on each side will be used for analysis. Warm-up exercises and two submaximal practice trials will be performed for preparation for maximal efforts and familiarization with the tests. A rest period of at least one minute between trials will be given to guarantee good physiological conditions to maximally perform. Further resting time will be allowed, if necessary, upon request of the participant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral overhead throwing athletes | – | Behavioral: Chronic exposure to unilateral overhead sports activityVolleyball attackers involved in competitive events ≥ 2 years, ≥18 years of age |
| Bilateral overhead athletes | – | Behavioral: Chronic exposure to bilateral overhead sports activitySwimmers involved in competitive events ≥ 2 years, ≥18 years of age |
| Non-athletes | – | Behavioral: Not exposedPersons not regularly involved in sports activities or occupational overhead tasks (e.g. construction workers), ≥18 years of age |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Athletes from sports organizations involved in competitive events and non-athletes from the general community/scholarly community
Key inclusion criteria (1 listed)
- Perform at least 150 degrees of arm elevation
Key exclusion criteria (5 listed)
- history of shoulder dislocation
- surgery in the upper extremity ≥ 6 months
- injury in the past month
- evident abnormalities in posture and movement of the upper body quadrant
- pain at the time of testing
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 |
|---|---|---|
| Chronic exposure to unilateral overhead sports activityOverhead sports athletes that have been chronically exposed (≥ 2 years) predominantly to specific unilateral overhead movement patterns of the dominant extremity ("throwing arm"), such as throwing or hitting a ball ("asymmetrical overhead sports). | Behavioural | Unilateral overhead throwing athletes |
| Chronic exposure to bilateral overhead sports activityOverhead sports athletes that have been chronically exposed (≥ 2 years) predominantly to bilateral overhead movement patterns of the upper extremities, such as swimmers ("symmetrical overhead sports"). | Behavioural | Bilateral overhead athletes |
| Not exposedPeople not engaged in regular sports competition/exercise training. | Behavioural | Non-athletes |
Primary outcome
Side-to-side differences in the unilateral seated shot put test (normalized distance thrown, in centimeters)
Time frame: Through study completion, an average of 1 year
The unilateral seated shot put test consists of pushing (not throwing) at shoulder height a ~3kg medicine ball as far and forward as possible while keeping the axial skeleton in contact with a wall, knees bent at a right angle, feet flat on the floor, and the non-testing arm resting on the lap.
Side-to-side differences in the upper quarter Y balance test (normalized maximal distance reached in each direction, in centimeters)
Time frame: Through study completion, an average of 1 year
The upper quarter Y balance test is performed through the assistance of a testing device (Y-Balance Test Kit), with the subject stabilizing his/her body weight with the upper extremity being tested while performing maximal reaching efforts with the free hand in three directions: medial, superolateral, and inferolateral.
5 secondary outcomes
Side-to-side differences in 3-dimensional scapular angular displacement (in degrees)
Time frame: Through study completion, an average of 1 year
Side-to-side differences in 3-dimensional humerus angular displacement (in degrees)
Time frame: Through study completion, an average of 1 year
Side-to-side differences in 3-dimensional thoracic angular displacement (in degrees)
Time frame: Through study completion, an average of 1 year
Side-to-side differences in the upper quarter Y balance test (total excursion, in centimeters)
Time frame: Through study completion, an average of 1 year
Side-to-side differences in the upper quarter Y balance test (overall performance score, in centimeters)
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by Universidade do Porto at 3 sites in Portugal.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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?
Results are not available in the source record.
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?
Side-to-side differences in the unilateral seated shot put test (normalized distance thrown, in centimeters) (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 6 Jan 2021.