Shoulder ImpingementNCT04290468
Dynamic Ultrasound in Shoulder Impingement
An observational study of Shoulder Impingement, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Impingement
- What is being tested?
- Dynamic ultrasound
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- All patients referred to the Radiology department with clinically suspected shoulder impingement. Inclusion Criteria:
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Ultrasound in Shoulder Impingement
- 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.
Read the detailed description
Shoulder impingement syndromes and degenerative rotator cuff (RC) disease represent the main causes of shoulder pain . Impingement is classified into four types, depending on the site of soft-tissue entrapment: sub acromial, sub coracoid, poster superior inner and anterosuperior inner impingement. The sub acromial impingement syndrome is by far the most common in practice. . The clinical symptoms of sub acromial impingement include nocturnal pain and progressive, limited range of motion. At clinical examination, there is a painful area at 80-120° elevation, which is worsened during downward movements Osteophytes, or an abnormal shape of the acromion, sub acromial spurs, and the acromioclavicular joint, are common causes of compression at the rotator cuff and the overlying subacromial-subdeltoid bursa . Ultrasonography (US) is a commonly performed examination for shoulder impingement, recommended by experts as the first-choice technique to evaluate various shoulder diseases. Shoulder impingement is the most common and well-recognized indication for dynamic US in the shoulder.
Dynamic evaluation can be done by shoulder abduction or flexion with the probe placed at the end of the acromion in the coronal plane or in the sagittal plane. The two important points to be checked for shoulder impingement are the humeral head depression and tendon/bursal impingement . Because humeral head depression is essential to make enough space for the rotator cuff to slide beneath the acromion, the center of the humeral head normally moves inferiorly in the latter half of the cycle during shoulder abduction. When the humeral head does not move inferiorly or abnormally moves superiorly, the space for the rotator cuffs and the subacromial-subdeltoid bursa decreases and subacromial impingement can occur .
Magnetic resonance imaging (MRI) is currently considered the reference standard for imaging of shoulder disorders. The strength of MRI lies in its ability to assess sonographically inaccessible areas such as labrum, deep parts of various ligaments, capsule, and areas obscured by bone . MRI is the imaging study of choice for classifying tendon retraction and assessing the shoulder musculature. Its main disadvantage is being a static evaluation of the shoulder joint . There are several advantages of Ultrasonography over MRI. Ultrasonography has the benefit of being a dynamic form of imaging as compared to the static MRI. Ultrasonography is portable, quick, and a more cost-effective method. It is also better tolerated by the patient and allows interaction with the patient, who can point at the symptomatic area, thus optimizing the diagnostic yield.
- Conditions
- Shoulder Impingement
- Being tested
- Dynamic ultrasound
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic ultrasoundDevice
Also called MRI
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of dynamic ultrasound findings with MRI
To determine the role of dynamic shoulder ultrasound in evaluation of patients with clinically suspected shoulder impingement
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Mar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Shoulder ImpingementStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ismail Ahmed Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290468
- Sponsor's protocol ID
- ultrasound in shoulder
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29927333Coats-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.
PubMed 29613881Pesquer 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.
PubMed 29445933Soker 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.
PubMed 29075914Do 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.
PubMed 27317919Daghir 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.
PubMed 21997670Michener 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.
PubMed 23736252
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound in Shoulder Impingement
- ClinicalTrials.gov ID
- NCT04290468
- Acronym / sponsor ID
- ultrasound in shoulder
- Conditions
- Shoulder Impingement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
Shoulder impingement syndromes and degenerative rotator cuff (RC) disease represent the main causes of shoulder pain . Impingement is classified into four types, depending on the site of soft-tissue entrapment: sub acromial, sub coracoid, poster superior inner and anterosuperior inner impingement. The sub acromial impingement syndrome is by far the most common in practice. . The clinical symptoms of sub acromial impingement include nocturnal pain and progressive, limited range of motion. At clinical examination, there is a painful area at 80-120° elevation, which is worsened during downward movements Osteophytes, or an abnormal shape of the acromion, sub acromial spurs, and the acromioclavicular joint, are common causes of compression at the rotator cuff and the overlying subacromial-subdeltoid bursa . Ultrasonography (US) is a commonly performed examination for shoulder impingement, recommended by experts as the first-choice technique to evaluate various shoulder diseases. Shoulder impingement is the most common and well-recognized indication for dynamic US in the shoulder.
Dynamic evaluation can be done by shoulder abduction or flexion with the probe placed at the end of the acromion in the coronal plane or in the sagittal plane. The two important points to be checked for shoulder impingement are the humeral head depression and tendon/bursal impingement . Because humeral head depression is essential to make enough space for the rotator cuff to slide beneath the acromion, the center of the humeral head normally moves inferiorly in the latter half of the cycle during shoulder abduction. When the humeral head does not move inferiorly or abnormally moves superiorly, the space for the rotator cuffs and the subacromial-subdeltoid bursa decreases and subacromial impingement can occur .
Magnetic resonance imaging (MRI) is currently considered the reference standard for imaging of shoulder disorders. The strength of MRI lies in its ability to assess sonographically inaccessible areas such as labrum, deep parts of various ligaments, capsule, and areas obscured by bone . MRI is the imaging study of choice for classifying tendon retraction and assessing the shoulder musculature. Its main disadvantage is being a static evaluation of the shoulder joint . There are several advantages of Ultrasonography over MRI. Ultrasonography has the benefit of being a dynamic form of imaging as compared to the static MRI. Ultrasonography is portable, quick, and a more cost-effective method. It is also better tolerated by the patient and allows interaction with the patient, who can point at the symptomatic area, thus optimizing the diagnostic yield.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients referred to the Radiology department with clinically suspected shoulder impingement. Inclusion Criteria:
Key exclusion criteria (5 listed)
- The following categories of patient will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic ultrasoundAlso: MRIThe 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). | Device | – |
Primary outcome
comparison of dynamic ultrasound findings with MRI
Time frame: Baseline
To determine the role of dynamic shoulder ultrasound in evaluation of patients with clinically suspected shoulder impingement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Background: PubMed 29927333Rowbotham 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.
- Background: PubMed 29613881Coats-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.
- Background: PubMed 29445933Pesquer 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.
- Background: PubMed 29075914Soker 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.
- Background: PubMed 27317919Do 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.
- Background: PubMed 21997670Daghir 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.
- Background: PubMed 23736252Michener 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Impingement, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Mohammed (01012561056, mrwaismail90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of dynamic ultrasound findings with MRI (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290468, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.