NCT04199988

Brief Summary

The purpose of this study was to investigate the reliability of posterior shoulder endurance test in overhead athletes and to compare the endurance of posterior shoulder muscles between athletes with and without shoulder pain.

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 all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

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

December 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

December 31, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

December 11, 2019

Last Update Submit

April 12, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Isometric Posterior Shoulder Endurance Test

    Isometric

    Measurements will be performed in two sessions (3 to 7 days)

  • Isotonic Posterior Shoulder Endurance Test

    Isotonic

    Measurements will be performed in two sessions (3 to 7 days)

Study Arms (2)

Athletes with shoulder pain

Overhead athletes with shoulder pain

Diagnostic Test: Posterior Shoulder Endurance Test

Athletes without shoulder pain

Overhead athletes without shoulder pain

Diagnostic Test: Posterior Shoulder Endurance Test

Interventions

Isometric posterior shoulder endurance test: In the prone position, the athlete's shoulder will be placed at horizontal abduction, and the time for maintaining this position will be recorded. Isotonic shoulder endurance test: In the prone position, the athlete's shoulder will be placed at horizontal abduction and asked to perform horizontal adduction-abduction, and the athlete will horizontally abducted-adducted his/her arm to 90 degrees at a cadence of 30 beats per minute. The number of repetitions will be recorded.

Athletes with shoulder painAthletes without shoulder pain

Eligibility Criteria

Age13 Years - 24 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Overhead athletes with and without shoulder pain

You may qualify if:

  • For all athletes:
  • Being between the ages of 13-24,
  • Participating to overhead sports (tennis, volleyball, handball, etc.),
  • Training at least 2-3 hours a week,
  • Active participation in training and competitions,
  • To be able to complete all assessments in the study,
  • For athletes with shoulder pain:
  • Shoulder pain is 3/10 or more in the Visual Analogue Scale.
  • For Athletes without shoulder pain:
  • No shoulder pain (0/10 according to Visual Analog Scale)
  • No history of a shoulder injury and/or shoulder symptoms requiring treatment for the past 1 year.
  • Having 90/100 or higher results in Kerlan-Jobe Orthopedic Clinical Shoulder \& Elbow Score

You may not qualify if:

  • Bilateral shoulder pain,
  • Upper extremity fracture history,
  • Surgical history of shoulder, cervical and thoracic region,
  • Diagnosis of musculoskeletal disease in the cervical region, elbow, and wrist,
  • Neck and shoulder pain with active/passive cervical spine movement,
  • Frozen shoulder,
  • Multidirectional joint hypermobility,
  • Having a systemic musculoskeletal disease,
  • Diagnosis of chest deformity and scoliosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University, Sports Medicine department

Balçova, İzmir, 35340, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sevgi Sevi YESİLYAPRAK, PhD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR
  • Birsu TOPÇUGİL KIRIK, MD

    Dokuz Eylul University

    STUDY CHAIR
  • Oğuz YÜKSEL, MD

    Dokuz Eylul University

    STUDY CHAIR
  • Oğuzcan GÖKÇAY, MD

    Dokuz Eylul University

    STUDY CHAIR

Central Study Contacts

Damla KARABAY, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 16, 2019

Study Start

December 31, 2019

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations