NCT02852785

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

July 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

July 25, 2016

Last Update Submit

January 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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)

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Borg's Rate of Perceived Exertion scale

    Through study completion, an average of 1 year

  • Visual Numeric Rating Scale score (0-10)

    Through study completion, an average of 1 year

Study Arms (5)

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

Behavioral: PNF D2 for flexion; low-to-moderate loading conditionBehavioral: PNF D2 for flexion; moderate-to-high loading conditionBehavioral: PNF D2 for extension; low-to-moderate loading conditionBehavioral: 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

Behavioral: PNF D2 for flexion; low-to-moderate loading conditionBehavioral: PNF D2 for flexion; moderate-to-high loading conditionBehavioral: PNF D2 for extension; low-to-moderate loading conditionBehavioral: 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),

Behavioral: PNF D2 for flexion; low-to-moderate loading conditionBehavioral: PNF D2 for flexion; moderate-to-high loading conditionBehavioral: PNF D2 for extension; low-to-moderate loading conditionBehavioral: 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

Behavioral: PNF D2 for flexion; low-to-moderate loading conditionBehavioral: PNF D2 for flexion; moderate-to-high loading conditionBehavioral: PNF D2 for extension; low-to-moderate loading conditionBehavioral: 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

Behavioral: PNF D2 for flexion; low-to-moderate loading conditionBehavioral: PNF D2 for flexion; moderate-to-high loading conditionBehavioral: PNF D2 for extension; low-to-moderate loading conditionBehavioral: PNF D2 for extension; moderate-to-high loading condition

Interventions

Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition

Asympt. athletes / scapula dyskinesisAsymptomatic bilateral overhead athletesAsymptomatic non-athletesAsymptomatic volleyball attackersSymptom. athletes / scapula dyskinesis

Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition

Asympt. athletes / scapula dyskinesisAsymptomatic bilateral overhead athletesAsymptomatic non-athletesAsymptomatic volleyball attackersSymptom. athletes / scapula dyskinesis

Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition

Asympt. athletes / scapula dyskinesisAsymptomatic bilateral overhead athletesAsymptomatic non-athletesAsymptomatic volleyball attackersSymptom. athletes / scapula dyskinesis

Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition

Asympt. athletes / scapula dyskinesisAsymptomatic bilateral overhead athletesAsymptomatic non-athletesAsymptomatic volleyball attackersSymptom. athletes / scapula dyskinesis

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Athletes from sports organizations involved in competitive events with pain and disability in the shoulder region

You may qualify if:

  • subjects who can perform at least 150 degrees of arm elevation

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Faculdade de Motricidade Humana, Universidade de Lisboa

Oeiras, Cruz-Quebrada, 1499-002, Portugal

Location

Escola Superior de Saúde, Instituto Politécnico de Leiria

Leiria, 2411-901, Portugal

Location

Faculdade de Desporto, Universidade do Porto

Porto, 4200-450, Portugal

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 2, 2016

Study Start

July 24, 2018

Primary Completion

April 1, 2021

Study Completion

July 1, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations