NCT04290468

Brief Summary

  • To evaluate the role of dynamic ultrasound in evaluation patient with clinically suspected shoulder joint impingement.
  • To assess the added value of dynamic ultrasonography to the static examination of patients with clinically suspected impingement.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

February 27, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

February 27, 2020

Last Update Submit

March 2, 2020

Conditions

Shoulder Impingement

Outcome Measures

Primary Outcomes (1)

  • comparison of dynamic ultrasound findings with MRI

    To determine the role of dynamic shoulder ultrasound in evaluation of patients with clinically suspected shoulder impingement

    Baseline

Interventions

Dynamic ultrasoundDEVICE

The ultrasound examination will be carried out blinded to the results of MRI using the Affiniti 70 ultrasound machine by Philips (USA) via a 5-12MHz linear transducer. MRI was performed on a high field system (1.5 Tesla) magnet units (Philips Acheiva).

Also known as: MRI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

sample size was determined by using G\*power version 3.1.9.2 for windows for power analysis .we estimated 37 patients to be included in the study with statistically power 95% and 0.05 as an alpha error

You may not qualify if:

  • The following categories of patient will be excluded from the study.
  • History of previous shoulder surgery.
  • History of joint dislocation.
  • Fracture to the shoulder girdle.
  • Patient with contraindication to MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Rowbotham EL, Grainger AJ. VIDEO: Ultrasound Evaluation of External Shoulder Impingement. AJR Am J Roentgenol. 2018 Aug;211(2):W122. doi: 10.2214/AJR.18.19534. Epub 2018 Jun 21.

    PMID: 29927333BACKGROUND

  • Coats-Thomas MS, Massimini DF, Warner JJP, Seitz AL. In Vivo Evaluation of Subacromial and Internal Impingement Risk in Asymptomatic Individuals. Am J Phys Med Rehabil. 2018 Sep;97(9):659-665. doi: 10.1097/PHM.0000000000000940.

    PMID: 29613881BACKGROUND

  • Pesquer L, Borghol S, Meyer P, Ropars M, Dallaudiere B, Abadie P. Multimodality imaging of subacromial impingement syndrome. Skeletal Radiol. 2018 Jul;47(7):923-937. doi: 10.1007/s00256-018-2875-y. Epub 2018 Feb 14.

    PMID: 29445933BACKGROUND

  • Soker G, Gulek B, Soker E, Kaya O, Inan I, Arslan M, Esen K, Memis D, Yilmaz C. Sonographic assessment of subacromial bursa distension during arm abduction: establishing a threshold value in the diagnosis of subacromial impingement syndrome. J Med Ultrason (2001). 2018 Apr;45(2):287-294. doi: 10.1007/s10396-017-0839-9. Epub 2017 Oct 26.

    PMID: 29075914BACKGROUND

  • Do HK, Lim JY. Ultrasonographic Evaluation and Feasibility of Posterosuperior Internal Impingement Syndrome: A Case Series. PM R. 2017 Jan;9(1):88-94. doi: 10.1016/j.pmrj.2016.06.008. Epub 2016 Jun 16.

    PMID: 27317919BACKGROUND

  • Daghir AA, Sookur PA, Shah S, Watson M. Dynamic ultrasound of the subacromial-subdeltoid bursa in patients with shoulder impingement: a comparison with normal volunteers. Skeletal Radiol. 2012 Sep;41(9):1047-53. doi: 10.1007/s00256-011-1295-z. Epub 2011 Oct 14.

    PMID: 21997670BACKGROUND

  • Michener LA, Subasi Yesilyaprak SS, Seitz AL, Timmons MK, Walsworth MK. Supraspinatus tendon and subacromial space parameters measured on ultrasonographic imaging in subacromial impingement syndrome. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):363-9. doi: 10.1007/s00167-013-2542-8. Epub 2013 Jun 5.

    PMID: 23736252BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Central Study Contacts

Marwa Mohammed

CONTACT

01012561056mrwaismail90@gmail.com

Noha Attia

CONTACT

01065742341nohamohamedali@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 2, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 4, 2020

Record last verified: 2020-03