3D Shoulder Kinematics During Throwing-related Movement Patterns Tasks in Upper Extremity Low-to-moderate/Moderate-to-high Loading Conditions

Shoulder Pain Clinical Trial

Official title:

3D Shoulder Kinematics During Throwing-related Movement Patterns Tasks in Upper Extremity Low-to-moderate/Moderate-to-high Loading Conditions

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02852785
• Other study ID #: FADEUP_PhDPT_NunoMorais_std#3
• Status: Enrolling by invitation
• Start date: July 24, 2018
• Est. completion date: July 2021

Study information

• Verified date: January 2021
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: July 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Behavioral:
• PNF D2 for flexion; low-to-moderate loading condition
Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition
• PNF D2 for flexion; moderate-to-high loading condition
Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition
• PNF D2 for extension; low-to-moderate loading condition
Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition
• PNF D2 for extension; moderate-to-high loading condition
Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition

Locations

Country	Name	City	State
Portugal	Escola Superior de Saúde, Instituto Politécnico de Leiria	Leiria
Portugal	Faculdade de Motricidade Humana, Universidade de Lisboa	Oeiras	Cruz-Quebrada
Portugal	Faculdade de Desporto, Universidade do Porto	Porto

Sponsors (3)

Lead Sponsor	Collaborator
Universidade do Porto	Instituto Politécnico de Leiria, University of Lisbon

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Borg's Rate of Perceived Exertion scale	Rate of Perceived Exertion (RPE) scale varies from 6 (no exertion) to 20 (very, very hard)	Through study completion, an average of 1 year
Secondary	Visual Numeric Rating Scale score (0-10)	A 11-point scale to rate pain intensity	Through study completion, an average of 1 year