Shoulder PainNCT02852785
3D Shoulder Kinematics During Throwing-related Movement Patterns Tasks in Upper Extremity Low-to-moderate/Moderate-to-high Loading Conditions
An observational study of Shoulder Pain, run by Universidade do Porto at 3 sites in Portugal.
Trial summary
The main purpose of this study is to characterize and compare the 3D shoulder kinematics bilaterally while performing functional movement patterns tests that hypothetically replicate the 5 main phases of the throwing cycle. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- PNF D2 for flexion; low-to-moderate loading condition, PNF D2 for flexion; moderate-to-high loading condition and PNF D2 for extension; low-to-moderate loading condition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 3 sitesPortugal
- Study dates
- 24 Jul 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Athletes from sports organizations involved in competitive events with pain and disability in the shoulder region
Who may be able to join
- subjects who can perform at least 150 degrees of arm elevation
Who cannot join
- subjects rating pain ≥8/10
- score 5 on any of the items of the Disabilities of Arm, Shoulder and Hand (DASH)
- pain elicited by provocation maneuvers of the neighboring regions (e.g., cervical spine).
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
The main purpose of this study is to characterize and compare the 3D shoulder kinematics bilaterally while performing functional movement patterns tests that hypothetically replicate the 5 main phases of the throwing cycle. The tests are based on diagonal D2 for flexion (early and late cocking of the arm) and D2 for extension (acceleration, deceleration and follow-through of the arm) of the upper extremity of proprioceptive neuromuscular facilitation techniques.
Read the detailed description
The 3D shoulder kinematics (thorax, scapula and humerus) will be collected in different groups of subjects with specific characteristics. To load the upper extremity during PNF D2 for flexion and extension directions, elastic tubing (Thera-Band) will be used as resistance. Selection of the two resistances will be according to a self-perceived ability of the subjects to consistently move a maximal amount of resistance (color) during PNF D2 flexion and extension tests for 15s and 30s, respectively. Each subject will be permitted to sample various resistances in order to assist in selecting the most appropriate load, with no more than three practice repetitions permitted per each resistance sampled.
To perform the tests, subjects will be sited in a standard chair without armrests, with their feet and lower legs placed on another standard chair, positioned just in front of their chair and the non-testing arm placed across the thoracic wall, to minimize the participation of the legs and trunk to upper extremity performance during testing. Elastic tubing will be anchored to a stable base to perform the diagonals (Thera-Band door anchor accessory or the opposite foot). Five repetitions of each test on both sides will be performed, in two different moments (5-10 minutes apart). A rate of 2 seconds per repetition will be employed during recordings using a metronome. A rest period will be given between trials to avoid fatigue. To perform the tests, subjects will begin/end with their hand on the contralateral hip and end/begin at head height and shoulder width. A marker will be placed in the latter position to standardize the start and end of hand position. The order of the tests (PNF D2 flexion and extension) and side (symptomatic/dominant and asymptomatic/non-dominant) will be randomized.
- Conditions
- Shoulder Pain
- Being tested
- PNF D2 for flexion; low-to-moderate loading condition, PNF D2 for flexion; moderate-to-high loading condition, PNF D2 for extension; low-to-moderate loading condition, PNF D2 for extension; moderate-to-high loading condition
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF D2 for flexion; low-to-moderate loading conditionBehavioural
Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition
PNF D2 for flexion; moderate-to-high loading conditionBehavioural
Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition
PNF D2 for extension; low-to-moderate loading conditionBehavioural
Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition
PNF D2 for extension; moderate-to-high loading conditionBehavioural
Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic volleyball attackers | Asymptomatic volleyball attackers involved in competitive events ≥ 2 years and no signs of postural and movement impairments of the upper body quadrant Receives: Behavioral: PNF D2 for flexion; low-to-moderate loading condition; Behavioral: PNF D2 for flexion; moderate-to-high loading condition; Behavioral: PNF D2 for extension; low-to-moderate loading condition; Behavioral: PNF D2 for extension; moderate-to-high loading condition | |
| Asymptomatic bilateral overhead athletes | Asymptomatic swimmers involved in competitive events ≥ 2 years and no signs of postural and movement impairments of the upper body quadrant Receives: Behavioral: PNF D2 for flexion; low-to-moderate loading condition; Behavioral: PNF D2 for flexion; moderate-to-high loading condition; Behavioral: PNF D2 for extension; low-to-moderate loading condition; Behavioral: PNF D2 for extension; moderate-to-high loading condition | |
| Asymptomatic non-athletes | Asymptomatic persons not regularly involved in sports activities or occupational overhead tasks (e.g. construction workers), Receives: Behavioral: PNF D2 for flexion; low-to-moderate loading condition; Behavioral: PNF D2 for flexion; moderate-to-high loading condition; Behavioral: PNF D2 for extension; low-to-moderate loading condition; Behavioral: PNF D2 for extension; moderate-to-high loading condition | |
| Asympt. athletes / scapula dyskinesis | Asymptomatic volleyball attackers involved in competitive events ≥ 2 years and with clinical evidence of scapula dyskinesis Receives: Behavioral: PNF D2 for flexion; low-to-moderate loading condition; Behavioral: PNF D2 for flexion; moderate-to-high loading condition; Behavioral: PNF D2 for extension; low-to-moderate loading condition; Behavioral: PNF D2 for extension; moderate-to-high loading condition | |
| Symptom. athletes / scapula dyskinesis | Volleyball attackers involved in competitive events ≥ 2 years and with clinical evidence of scapula dyskinesis and complaints of shoulder pain and disability Receives: Behavioral: PNF D2 for flexion; low-to-moderate loading condition; Behavioral: PNF D2 for flexion; moderate-to-high loading condition; Behavioral: PNF D2 for extension; low-to-moderate loading condition; Behavioral: PNF D2 for extension; moderate-to-high loading condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side-to-side differences in 3-dimensional scapular angular displacement (in degrees)
The angular position and displacement of the scapula in the 3 planes of [lateral/medial (upward/downward) rotation, protraction/retraction (internal/external rotation), anterior/posterior tilting] at 4 key events of the simulated throwing motion during the two loading conditions (1, initiation of humeral motion; 2, maximum humeral horizontal abduction relative to the trunk; 3, maximum humeral external rotation; 4, maximum humeral internal rotation)
Measured: Through study completion, an average of 1 year
Side-to-side differences in 3-dimensional humerus angular displacement (in degrees)
The angular position and displacement of the humerus in the 3 planes of (plane of elevation, elevation/depression, axial rotation) at 4 key events of the simulated throwing motion during the two loading conditions (1, initiation of humeral motion; 2, maximum humeral horizontal abduction relative to the trunk; 3, maximum humeral external rotation; 4, maximum humeral internal rotation)
Measured: Through study completion, an average of 1 year
Side-to-side differences in 3-dimensional thoracic angular displacement (in degrees)
The angular position and displacement of the thorax in the 3 planes of [flexion/extension, lateral rotation (inclination), axial rotation] at 4 key events of the simulated throwing motion during the two loading conditions (1, initiation of humeral motion; 2, maximum humeral horizontal abduction relative to the trunk; 3, maximum humeral external rotation; 4, maximum humeral internal rotation)
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Borg's Rate of Perceived Exertion scale
Rate of Perceived Exertion (RPE) scale varies from 6 (no exertion) to 20 (very, very hard)
Measured: Through study completion, an average of 1 year
Visual Numeric Rating Scale score (0-10)
A 11-point scale to rate pain intensity
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 start24 Jul 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
- 150 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
- NCT02852785
- Sponsor's protocol ID
- FADEUP_PhDPT_NunoMorais_std#3
- Status last verified
- Jan 2021
- First submitted
- 25 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
- 3D Shoulder Kinematics During Throwing-related Movement Patterns Tasks in Upper Extremity Low-to-moderate/Moderate-to-high Loading Conditions
- ClinicalTrials.gov ID
- NCT02852785
- Acronym / sponsor ID
- FADEUP_PhDPT_NunoMorais_std#3
- Conditions
- Shoulder Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- University of Lisbon, Instituto Politécnico de Leiria
- Study start
- 24 Jul 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.
The main purpose of this study is to characterize and compare the 3D shoulder kinematics bilaterally while performing functional movement patterns tests that hypothetically replicate the 5 main phases of the throwing cycle. The tests are based on diagonal D2 for flexion (early and late cocking of the arm) and D2 for extension (acceleration, deceleration and follow-through of the arm) of the upper extremity of proprioceptive neuromuscular facilitation techniques.
Detailed description
The 3D shoulder kinematics (thorax, scapula and humerus) will be collected in different groups of subjects with specific characteristics. To load the upper extremity during PNF D2 for flexion and extension directions, elastic tubing (Thera-Band) will be used as resistance. Selection of the two resistances will be according to a self-perceived ability of the subjects to consistently move a maximal amount of resistance (color) during PNF D2 flexion and extension tests for 15s and 30s, respectively. Each subject will be permitted to sample various resistances in order to assist in selecting the most appropriate load, with no more than three practice repetitions permitted per each resistance sampled.
To perform the tests, subjects will be sited in a standard chair without armrests, with their feet and lower legs placed on another standard chair, positioned just in front of their chair and the non-testing arm placed across the thoracic wall, to minimize the participation of the legs and trunk to upper extremity performance during testing. Elastic tubing will be anchored to a stable base to perform the diagonals (Thera-Band door anchor accessory or the opposite foot). Five repetitions of each test on both sides will be performed, in two different moments (5-10 minutes apart). A rate of 2 seconds per repetition will be employed during recordings using a metronome. A rest period will be given between trials to avoid fatigue. To perform the tests, subjects will begin/end with their hand on the contralateral hip and end/begin at head height and shoulder width. A marker will be placed in the latter position to standardize the start and end of hand position. The order of the tests (PNF D2 flexion and extension) and side (symptomatic/dominant and asymptomatic/non-dominant) will be randomized.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic volleyball attackers | – | Behavioral: PNF D2 for flexion; low-to-moderate loading condition, Behavioral: PNF D2 for flexion; moderate-to-high loading condition, Behavioral: PNF D2 for extension; low-to-moderate loading condition, Behavioral: PNF D2 for extension; moderate-to-high loading conditionAsymptomatic volleyball attackers involved in competitive events ≥ 2 years and no signs of postural and movement impairments of the upper body quadrant |
| Asymptomatic bilateral overhead athletes | – | Behavioral: PNF D2 for flexion; low-to-moderate loading condition, Behavioral: PNF D2 for flexion; moderate-to-high loading condition, Behavioral: PNF D2 for extension; low-to-moderate loading condition, Behavioral: PNF D2 for extension; moderate-to-high loading conditionAsymptomatic swimmers involved in competitive events ≥ 2 years and no signs of postural and movement impairments of the upper body quadrant |
| Asymptomatic non-athletes | – | Behavioral: PNF D2 for flexion; low-to-moderate loading condition, Behavioral: PNF D2 for flexion; moderate-to-high loading condition, Behavioral: PNF D2 for extension; low-to-moderate loading condition, Behavioral: PNF D2 for extension; moderate-to-high loading conditionAsymptomatic persons not regularly involved in sports activities or occupational overhead tasks (e.g. construction workers), |
| Asympt. athletes / scapula dyskinesis | – | Behavioral: PNF D2 for flexion; low-to-moderate loading condition, Behavioral: PNF D2 for flexion; moderate-to-high loading condition, Behavioral: PNF D2 for extension; low-to-moderate loading condition, Behavioral: PNF D2 for extension; moderate-to-high loading conditionAsymptomatic volleyball attackers involved in competitive events ≥ 2 years and with clinical evidence of scapula dyskinesis |
| Symptom. athletes / scapula dyskinesis | – | Behavioral: PNF D2 for flexion; low-to-moderate loading condition, Behavioral: PNF D2 for flexion; moderate-to-high loading condition, Behavioral: PNF D2 for extension; low-to-moderate loading condition, Behavioral: PNF D2 for extension; moderate-to-high loading conditionVolleyball attackers involved in competitive events ≥ 2 years and with clinical evidence of scapula dyskinesis and complaints of shoulder pain and disability |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Athletes from sports organizations involved in competitive events with pain and disability in the shoulder region
Key inclusion criteria (1 listed)
- subjects who can perform at least 150 degrees of arm elevation
Key exclusion criteria (3 listed)
- subjects rating pain ≥8/10
- score 5 on any of the items of the Disabilities of Arm, Shoulder and Hand (DASH)
- pain elicited by provocation maneuvers of the neighboring regions (e.g., cervical spine).
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 |
|---|---|---|
| PNF D2 for flexion; low-to-moderate loading conditionExposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition | Behavioural | Asympt. athletes / scapula dyskinesis, Asymptomatic bilateral overhead athletes, Asymptomatic non-athletes, Asymptomatic volleyball attackers, Symptom. athletes / scapula dyskinesis |
| PNF D2 for flexion; moderate-to-high loading conditionExposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition | Behavioural | Asympt. athletes / scapula dyskinesis, Asymptomatic bilateral overhead athletes, Asymptomatic non-athletes, Asymptomatic volleyball attackers, Symptom. athletes / scapula dyskinesis |
| PNF D2 for extension; low-to-moderate loading conditionExposure to upper extremity PNF D2 for extension during low-to-moderate loading condition | Behavioural | Asympt. athletes / scapula dyskinesis, Asymptomatic bilateral overhead athletes, Asymptomatic non-athletes, Asymptomatic volleyball attackers, Symptom. athletes / scapula dyskinesis |
| PNF D2 for extension; moderate-to-high loading conditionExposure to upper extremity PNF D2 for extension during moderate-to-high loading condition | Behavioural | Asympt. athletes / scapula dyskinesis, Asymptomatic bilateral overhead athletes, Asymptomatic non-athletes, Asymptomatic volleyball attackers, Symptom. athletes / scapula dyskinesis |
Primary outcome
Side-to-side differences in 3-dimensional scapular angular displacement (in degrees)
Time frame: Through study completion, an average of 1 year
The angular position and displacement of the scapula in the 3 planes of [lateral/medial (upward/downward) rotation, protraction/retraction (internal/external rotation), anterior/posterior tilting] at 4 key events of the simulated throwing motion during the two loading conditions (1, initiation of humeral motion; 2, maximum humeral horizontal abduction relative to the trunk; 3, maximum humeral external rotation; 4, maximum humeral internal rotation)
Side-to-side differences in 3-dimensional humerus angular displacement (in degrees)
Time frame: Through study completion, an average of 1 year
The angular position and displacement of the humerus in the 3 planes of (plane of elevation, elevation/depression, axial rotation) at 4 key events of the simulated throwing motion during the two loading conditions (1, initiation of humeral motion; 2, maximum humeral horizontal abduction relative to the trunk; 3, maximum humeral external rotation; 4, maximum humeral internal rotation)
Side-to-side differences in 3-dimensional thoracic angular displacement (in degrees)
Time frame: Through study completion, an average of 1 year
The angular position and displacement of the thorax in the 3 planes of [flexion/extension, lateral rotation (inclination), axial rotation] at 4 key events of the simulated throwing motion during the two loading conditions (1, initiation of humeral motion; 2, maximum humeral horizontal abduction relative to the trunk; 3, maximum humeral external rotation; 4, maximum humeral internal rotation)
2 secondary outcomes
Borg's Rate of Perceived Exertion scale
Time frame: Through study completion, an average of 1 year
Visual Numeric Rating Scale score (0-10)
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 3 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 3-dimensional scapular angular displacement (in degrees) (time frame: Through study completion, an average of 1 year). The study lists 3 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.