NCT05305196

Brief Summary

The aim of this study is to investigate the effects of shoulder eccentric exercise training on shoulder mobility, rotator cuff strength, pain and dysfunction, scapular kinematics and muscle activation in symptomatic overhead athletes with posterior shoulder tightness.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 9, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

August 23, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

February 17, 2022

Last Update Submit

August 22, 2023

Conditions

Keywords

Posterior shoulder tightnessEccentric exerciseShoulder impingement syndrome

Outcome Measures

Primary Outcomes (5)

  • Shoulder range of motion (measured with goniometer)

    Shoulder external rotation, internal rotation, horizontal adduction range of motion in shoulder flexion 90 degrees

    4 weeks

  • Rotator cuff functional strength ratio (Pro 4, Biodex Medical Systems, Inc., Shirley, NY, USA)

    Eccentric strength of shoulder external rotator and concentric strength of shoulder internal rotator are measured with isokinetic

    4 weeks

  • Shoulder pain

    Pain is measured with Visual Analogue scale (VAS) Score range from 0 to 10. Scoring of 0 represents no pain and scoring of 10 represents pain as bad as it could possibly be.

    4 weeks

  • Shoulder function

    Shoulder function is measured with Disability of the Arm, Shoulder and Hand questionnaire (DASH) Score range from 0 to 100. The higher of the score, the more disability.

    4 weeks

  • Shoulder endurance test

    Participants will be instructed to execute a shoulder endurance test with the theraband®. Participants are asked to place their tested arm in a shoulder forward flexion 90-degree position, holding a 1-m long theraband® fixed at shoulder height on a graduated stick. Then, they are asked to pull the theraband® from the starting position to a 90-90 ending position at an alternated cadence given by a metronome. Males were asked to pull a green theraband® (2.1 kg) and females a red theraband ® (1.7 kg).

    4 weeks

Secondary Outcomes (2)

  • Electromagnetic tracking system (Liberty electromagnetic tracking system, Polhemus , Colchester, VT,)

    4 weeks

  • Surface electromyography (TeleMyo 2400T G2, Noraxon USA Inc., Scottsdale, AZ, USA)

    4 weeks

Study Arms (2)

Eccentric-focused exercise group

EXPERIMENTAL

Three eccentric-focused exercises addition to the general treatment group

Other: Eccentric-focused exercisesOther: Stretching exercisesOther: Hot packOther: Massage

General treatment group

ACTIVE COMPARATOR

hot pack application on shoulder region upper trapezius massage two stretching exercises (modified sleeper stretch and modified cross-body stretch)

Other: Stretching exercisesOther: Hot packOther: Massage

Interventions

Three eccentric-focused exercises: 1. Shoulder external rotator eccentric contraction in shoulder abduction 90 degree 2. Shoulder external rotator eccentric contraction in shoulder abduction 0 degree 3. Shoulder abductor eccentric contraction in shoulder abduction 90 degree

Eccentric-focused exercise group

1. Modified sleeper stretch 2. Modified cross-body stretch

Eccentric-focused exercise groupGeneral treatment group

Hot pack application on shoulder region

Eccentric-focused exercise groupGeneral treatment group
MassageOTHER

Massage for upper trapezius

Eccentric-focused exercise groupGeneral treatment group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participate in overhead sports over 4 hours per week
  • Age between 20 to 50 years old
  • Glenohumeral joint range of motion deficit: Shoulder internal rotation loss more than 15 degrees compared to the non-dominant side and total arc of motion loss more than 5 degrees or/and horizontal adduction range of motion lo more than 15 degrees compared to the non-dominant side
  • Shoulder impingement syndrome criteria

You may not qualify if:

  • History of shoulder dislocation, fracture and operation
  • History of direct contact in upper extremities or cervical region in the past one month
  • Shoulder pain or neurological symptom caused by cervical problem
  • VAS more than 5 during shoulder elevation
  • Receive treatment for posterior shoulder tightness in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, Beitou, 112304, Taiwan

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Muscle Stretching ExercisesMassage

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapy, Soft TissueMusculoskeletal ManipulationsComplementary Therapies

Central Study Contacts

ShaoYang Huang, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 31, 2022

Study Start

November 9, 2022

Primary Completion

August 22, 2023

Study Completion

August 31, 2023

Last Updated

August 23, 2023

Record last verified: 2023-03

Locations