NCT03658707

Brief Summary

The aim of this study is to determine the validity and reliability of the Turkish version of the Functional Shoulder Score in Turkish patients with subacromial impingement syndrome (SIS).

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
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 23, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

4.6 years

First QC Date

September 2, 2018

Last Update Submit

July 26, 2022

Conditions

Keywords

Functional shoulder scorequestionnairesubacromial impingement syndrome

Outcome Measures

Primary Outcomes (1)

  • Functional Shoulder Score

    The questionnaire includes 11 items: One is about shoulder pain intensity and 10 is about the shoulder function. The minimum score is 0 (worst) and the maximum score is 100 (best).

    Baseline - within 3-7 days after the baseline

Secondary Outcomes (5)

  • Modified Constant Murley Shoulder Score

    Baseline

  • American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form

    Baseline

  • Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)

    Baseline

  • Western Ontario Rotator Cuff (WORC) index

    Baseline

  • Global rating scale

    Baseline

Interventions

Shoulder questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with subacromial impingement syndrome from the outpatient clinic of the Dokuz Eylul University, Faculty of Medicine, Department of Orthopedics and Traumatology.

You may qualify if:

  • Diagnosis of subacromial impingement syndrome (Michener et al, 2009)
  • To read and understand Turkish

You may not qualify if:

  • % limitation of passive shoulder range of motion in ≥ 2 planes of motion
  • Glenohumeral instability
  • Fracture or surgery history in the shoulder
  • Another diagnosis that may affect shoulder function (frozen shoulder, primary shoulder arthritis, inflammatory/ neoplastic/neurological conditions, cervical spine induced pain)
  • Systemic musculoskeletal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sevgi Sevi YESILYAPRAK, PhD

    Dokuz Eylul University

    STUDY DIRECTOR
  • Halime Ezgi TURKSAN

    Dokuz Eylul University

    STUDY CHAIR
  • Mehmet ERDURAN, MD

    Dokuz Eylul University

    STUDY CHAIR
  • Damla KARABAY, MSc

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 2, 2018

First Posted

September 5, 2018

Study Start

November 23, 2018

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations