NCT05996510

Brief Summary

Chronic shoulder pain is one of the most common diseases affecting the quality of life today. Although there are multiple causes, one of the most common causes is shoulder impingement syndrome. Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions that are usually evaluated, the visualization of the Suprascapular notch is usually observed during injection. The connection between the suprascapular notch and the shoulder joint has been demonstrated in different studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 4, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

August 4, 2023

Last Update Submit

May 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Suprascapular notch cross-sectional area measurement

    The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.

    baseline

Secondary Outcomes (2)

  • Visual Analogue Scale

    baseline

  • Shoulder Pain and Disability Index (SPADI)

    baseline

Study Arms (2)

diseased shoulder

ACTIVE COMPARATOR
Device: ultrasound

sturdy shoulder

ACTIVE COMPARATOR
Device: ultrasound

Interventions

Shoulder ultrasound is performed using a linear ultrasound probe. The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.

Also known as: shoulder ultrasound
diseased shouldersturdy shoulder

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic shoulder pain
  • years
  • who agreed to participate in the study

You may not qualify if:

  • Lymphoproliferative diseases and other neoplasms
  • Uncontrolled arterial hypertension
  • Metabolic syndrome
  • Uncontrolled diabetes mellitus
  • Mental retardation
  • Antidepressant use
  • Autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder PainShoulder Impingement Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • korgün ökmen

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR
  • Lale altan inceoğlu, phd

    uludağ university faculty of medicine

    STUDY CHAIR
  • ugur ertem, M.D.

    uludağ university faculty of medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 18, 2023

Study Start

August 10, 2023

Primary Completion

October 10, 2023

Study Completion

October 11, 2023

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations