Shoulder PainNCT05132959
The Morphometric Parameters of Shoulder and Supraspinatus Tendinosis
An observational study of Shoulder Pain and Tendinosis, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
Supraspinatus tendinosis one of the most common pathologies of the musculoskeletal system.The aim of this study to investigate the relationship between supraspinatus tendinosis and shoulder morphology with magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Pain, Tendinosis
- What is being tested?
- magnetic resonance imaging
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Sep 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 Any age
- Child, Adult, Older adult
Study population: Patients with shoulder pain due to shoulder pathology and another pathology and who have MRI images of the shoulder were recrutied into the study.
Who may be able to join
- Patients with shoulder pain or healthy controls
Who cannot join
- Patients with a history of shoulder surgery or trauma, inflammation of the shoulder joint, inflammatory arthritis, space-occupying mass lesions, rupture of the supraspinatus tendon or calcific tendinitis were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between The Morphometric Parameters of Shoulder and Supraspinatus Tendinosis
Supraspinatus tendinosis one of the most common pathologies of the musculoskeletal system.The aim of this study to investigate the relationship between supraspinatus tendinosis and shoulder morphology with magnetic resonance imaging (MRI).
Read the detailed description
Supraspinatus tendinosis one of the most common pathologies of the musculoskeletal system. It affects 15-50% of the population and its prevalence increases with age. It can lead to useful disability as well as ease of life. Weight, old age and traumas as recurrent risk for SS tendosis. In the literature, there are a large number of small and small numbers among the biology of supraspinologicus tears .The aim of this study to investigate the relationship between supraspinatus tendinosis and shoulder morphology with magnetic resonance imaging (MRI).
- Conditions
- Shoulder Pain, Tendinosis
- Being tested
- magnetic resonance imaging
- Medical subject headings
- Shoulder Pain, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingDiagnostic test
The MRI images of patients who had undergone to shoulder magnetic resonance imaging because of shoulder pain or another pathology were studied
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Patients with supraspinatus tendinosis Receives: Diagnostic Test: magnetic resonance imaging | |
| Control Group | Patients without shoulder pain Receives: Diagnostic Test: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coracoacromial ligament thickness
It was measured at the insertion site of the coracoacromial ligament in the lateral part of the acromion
Measured: three months
Acromial angle (delta angle)
It is the angle between the line parallel to the lower face of the acromion and the ground plane
Measured: three months
Acromioglenoid angle
It is the angle between the lower surface of the acromion (a) and the line parallel to the glenoid bone structure
Measured: three months
Axial supraspinatus glenoid angle
It is the angle between the supraspinatus fossa (a) and the line parallel to the glenoid bone structure
Measured: at the same time
Coronal supraspinatus glenoid angle
It is the angle between the line parallel to the supraspinatus fossa and the line parallel to the glenoid bone structure
Measured: three months
Acromiohumeral distance
It is the narrowest distance between the acromion and the humerus
Measured: three months
Coracoacromial arch angle
: It is the angle between the axis of the coracoacromial ligament (running from the coracoid process to the acromion) and the line parallel to the lower surface of the acromion
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Jan 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Yüksel, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132959
- Sponsor's protocol ID
- 12-06
- Status last verified
- Nov 2021
- First submitted
- 14 Sep 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between The Morphometric Parameters of Shoulder and Supraspinatus Tendinosis
- ClinicalTrials.gov ID
- NCT05132959
- Acronym / sponsor ID
- 12-06
- Conditions
- Shoulder Pain, Tendinosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 24 Nov 2021 (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.
Supraspinatus tendinosis one of the most common pathologies of the musculoskeletal system.The aim of this study to investigate the relationship between supraspinatus tendinosis and shoulder morphology with magnetic resonance imaging (MRI).
Detailed description
Supraspinatus tendinosis one of the most common pathologies of the musculoskeletal system. It affects 15-50% of the population and its prevalence increases with age. It can lead to useful disability as well as ease of life. Weight, old age and traumas as recurrent risk for SS tendosis. In the literature, there are a large number of small and small numbers among the biology of supraspinologicus tears .The aim of this study to investigate the relationship between supraspinatus tendinosis and shoulder morphology with magnetic resonance imaging (MRI).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Diagnostic Test: magnetic resonance imagingPatients with supraspinatus tendinosis |
| Control Group | – | Diagnostic Test: magnetic resonance imagingPatients without shoulder pain |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with shoulder pain due to shoulder pathology and another pathology and who have MRI images of the shoulder were recrutied into the study.
Key inclusion criteria (1 listed)
- Patients with shoulder pain or healthy controls
Key exclusion criteria (1 listed)
- Patients with a history of shoulder surgery or trauma, inflammation of the shoulder joint, inflammatory arthritis, space-occupying mass lesions, rupture of the supraspinatus tendon or calcific tendinitis were 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 |
|---|---|---|
| magnetic resonance imagingThe MRI images of patients who had undergone to shoulder magnetic resonance imaging because of shoulder pain or another pathology were studied | Diagnostic test | Control Group, Patient Group |
Primary outcome
Coracoacromial ligament thickness
Time frame: three months
It was measured at the insertion site of the coracoacromial ligament in the lateral part of the acromion
Acromial angle (delta angle)
Time frame: three months
It is the angle between the line parallel to the lower face of the acromion and the ground plane
Acromioglenoid angle
Time frame: three months
It is the angle between the lower surface of the acromion (a) and the line parallel to the glenoid bone structure
Axial supraspinatus glenoid angle
Time frame: at the same time
It is the angle between the supraspinatus fossa (a) and the line parallel to the glenoid bone structure
Coronal supraspinatus glenoid angle
Time frame: three months
It is the angle between the line parallel to the supraspinatus fossa and the line parallel to the glenoid bone structure
Acromiohumeral distance
Time frame: three months
It is the narrowest distance between the acromion and the humerus
Coracoacromial arch angle
Time frame: three months
: It is the angle between the axis of the coracoacromial ligament (running from the coracoid process to the acromion) and the line parallel to the lower surface of the acromion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Tendinosis, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coracoacromial ligament thickness (time frame: three months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2021.