Supraspinatus Tear or Rupture, Not Specified as TraumaticNCT03171883
Ultrasound of Supraspinatus Muscle Tears
An observational study of Supraspinatus Tear or Rupture, Not Specified as Traumatic, run by Assiut University.
Trial summary
The supraspinatus is a relatively small muscle of the upper back that runs from the supraspinatus fossa superior portion of the scapula to the greater tubercle of the humerus. It is one of the four rotator cuff muscles and also abducts the arm at the shoulder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Supraspinatus Tear or Rupture, Not Specified as Traumatic
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of different age groups presented with clinical diagnosis of shoulder impingement
Who may be able to join
- patients of different age groups presented with clinical diagnosis department of shoulder impingement and diagnosed by magnetic resonance imaging as supraspinatus
Who cannot join
- patients with previous shoulder surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Value of Ultrasound in the Diagnosis of Supraspinatus Muscle Tears
The supraspinatus is a relatively small muscle of the upper back that runs from the supraspinatus fossa superior portion of the scapula to the greater tubercle of the humerus. It is one of the four rotator cuff muscles and also abducts the arm at the shoulder. A supraspinatus tear is a tear or rupture of the tendon of the supraspinatus muscle.
Read the detailed description
Many pathological conditions as trauma (whether acute or chronic), inflammation or instability may cause supraspinatus muscle disease which is one of the commonest cause of shoulder pain and malfunction.
Supraspinatus muscle failure usually results from tendinopathy that transforms from partial to full thickness tears.
Basically shoulder impingement is a clinical diagnosis. The role of imaging in such condition is to identify the causal factors as well as to detect the involvement of tendon injuries and its extension as tears of the cuff muscles is difficult to be identified clinically.
The decision making in the treatment of the supraspinatus muscle tears relies mainly upon the correct diagnosis of the type and extent of the tear. According to the diagnosis whether conservative or surgical treatment is chosen, even the type of the surgical intervention (open or arthroscopic) would differ according to the diagnosis.
In addition identifying the extent of tendons retraction and the condition of the ruptured edges, as well as the quality of the muscle itself influences the management policy.
To evaluate the painful shoulder a variety of imaging tests have been used; yet, for diagnosing a supraspinatus muscle tear the standard imaging modalities such as unenhanced magnetic resonance imaging, indirect and direct magnetic resonant arthrography, and ultrasound are used.
US of the shoulder is utilized increasingly in healthcare settings to assess the integrity of the supraspinatus muscle. It is a non-invasive examination with practically no side effects. It is beneficial in the dynamic examination of the tendon during movement of the shoulder .
- Medical subject headings
- Rupture
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients diagnosed as supraspinatus lesions by ultrasound
Evaluation the effectiveness of ultrasound in the assessment of supraspinatus muscle tears compared with results of shoulder arthroscopy as a gold standard method.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Supraspinatus Tear or Rupture, Not Specified as TraumaticStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry Ayad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171883
- Sponsor's protocol ID
- USSPMT
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lewis JS. Rotator cuff tendinopathy: a model for the continuum of pathology and related management. Br J Sports Med. 2010 Oct;44(13):918-23. doi: 10.1136/bjsm.2008.054817. Epub 2009 Apr 12.
PubMed 19364757Fotiadou AN, Vlychou M, Papadopoulos P, Karataglis DS, Palladas P, Fezoulidis IV. Ultrasonography of symptomatic rotator cuff tears compared with MR imaging and surgery. Eur J Radiol. 2008 Oct;68(1):174-9. doi: 10.1016/j.ejrad.2007.11.002. Epub 2007 Dec 21.
PubMed 18160242Whiting P, Rutjes AW, Reitsma JB, Bossuyt PM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol. 2003 Nov 10;3:25. doi: 10.1186/1471-2288-3-25.
PubMed 14606960Le Corroller T, Cohen M, Aswad R, Pauly V, Champsaur P. Sonography of the painful shoulder: role of the operator's experience. Skeletal Radiol. 2008 Nov;37(11):979-86. doi: 10.1007/s00256-008-0539-z. Epub 2008 Jul 24.
PubMed 18651142
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Ultrasound in the Diagnosis of Supraspinatus Muscle Tears
- ClinicalTrials.gov ID
- NCT03171883
- Acronym / sponsor ID
- USSPMT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 31 May 2017 (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.
The supraspinatus is a relatively small muscle of the upper back that runs from the supraspinatus fossa superior portion of the scapula to the greater tubercle of the humerus. It is one of the four rotator cuff muscles and also abducts the arm at the shoulder. A supraspinatus tear is a tear or rupture of the tendon of the supraspinatus muscle.
Detailed description
Many pathological conditions as trauma (whether acute or chronic), inflammation or instability may cause supraspinatus muscle disease which is one of the commonest cause of shoulder pain and malfunction.
Supraspinatus muscle failure usually results from tendinopathy that transforms from partial to full thickness tears.
Basically shoulder impingement is a clinical diagnosis. The role of imaging in such condition is to identify the causal factors as well as to detect the involvement of tendon injuries and its extension as tears of the cuff muscles is difficult to be identified clinically.
The decision making in the treatment of the supraspinatus muscle tears relies mainly upon the correct diagnosis of the type and extent of the tear. According to the diagnosis whether conservative or surgical treatment is chosen, even the type of the surgical intervention (open or arthroscopic) would differ according to the diagnosis.
In addition identifying the extent of tendons retraction and the condition of the ruptured edges, as well as the quality of the muscle itself influences the management policy.
To evaluate the painful shoulder a variety of imaging tests have been used; yet, for diagnosing a supraspinatus muscle tear the standard imaging modalities such as unenhanced magnetic resonance imaging, indirect and direct magnetic resonant arthrography, and ultrasound are used.
US of the shoulder is utilized increasingly in healthcare settings to assess the integrity of the supraspinatus muscle. It is a non-invasive examination with practically no side effects. It is beneficial in the dynamic examination of the tendon during movement of the shoulder .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of different age groups presented with clinical diagnosis of shoulder impingement
Key inclusion criteria (1 listed)
- patients of different age groups presented with clinical diagnosis department of shoulder impingement and diagnosed by magnetic resonance imaging as supraspinatus
Key exclusion criteria (1 listed)
- patients with previous shoulder surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients diagnosed as supraspinatus lesions by ultrasound
Time frame: 2 years
Evaluation the effectiveness of ultrasound in the assessment of supraspinatus muscle tears compared with results of shoulder arthroscopy as a gold standard method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 19364757Lewis JS. Rotator cuff tendinopathy: a model for the continuum of pathology and related management. Br J Sports Med. 2010 Oct;44(13):918-23. doi: 10.1136/bjsm.2008.054817. Epub 2009 Apr 12.
- Background: PubMed 18160242Fotiadou AN, Vlychou M, Papadopoulos P, Karataglis DS, Palladas P, Fezoulidis IV. Ultrasonography of symptomatic rotator cuff tears compared with MR imaging and surgery. Eur J Radiol. 2008 Oct;68(1):174-9. doi: 10.1016/j.ejrad.2007.11.002. Epub 2007 Dec 21.
- Background: PubMed 14606960Whiting P, Rutjes AW, Reitsma JB, Bossuyt PM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol. 2003 Nov 10;3:25. doi: 10.1186/1471-2288-3-25.
- Background: PubMed 18651142Le Corroller T, Cohen M, Aswad R, Pauly V, Champsaur P. Sonography of the painful shoulder: role of the operator's experience. Skeletal Radiol. 2008 Nov;37(11):979-86. doi: 10.1007/s00256-008-0539-z. Epub 2008 Jul 24.
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 Supraspinatus Tear or Rupture, Not Specified as Traumatic, 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 1 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 31 May 2017. 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 Mohammad Koriem assistant professor (00201003331902, koriemomar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients diagnosed as supraspinatus lesions by ultrasound (time frame: 2 years). 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 NCT03171883, which also lists 4 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 31 May 2017.