Shoulder PainNCT03546777
Evaluation Coroacromial Ligament Thickness
An observational study of Shoulder Pain, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to determine the relationship between pathologic findings and coracoacromial ligament thickness in magnetic resonance imaging in shoulder pain patients. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- magnetic resonance imaging
- Type of treatment
- Medical device
- How many people
- 253 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 1 Aug 2017
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with shoulder pain
Who may be able to join
- Patients aged over 15 years diagnosed with shoulder pain
Who cannot join
- Sensation and reflexes loss in the upper extremity
- Limitation in passive shoulder movements on physical examination
- Systemic rheumatic disease
- Diabetes mellitus
- Malignant disease
- Active infection
Show all 9Show fewer
- Intraarticular injection
- Trauma
- History of surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University
Isparta, Province, 32
About this study
Official title: Should the Coroacromial Ligament be Evaluated in Shoulder Magnetic Resonance Imaging?
In this study, it was aimed to determine the relationship between pathologic findings and coracoacromial ligament thickness in magnetic resonance imaging in shoulder pain patients.
Read the detailed description
The coracoacromial ligament, which is part of the coracoacromial arch, plays an important role in shoulder biomechanics, joint stability and proprioception. Age-related changes due to chronic stress and cellular impairment may contribute to thickening and stiffening of the coracoacromial ligament to rupture the rotator cuff and development of shoulder pathologies such as impingement syndrome. In this study, it was aimed to determine the relationship between pathologic findings and coracoacromial ligament thickness in magnetic resonance imaging in shoulder pain patients. Secondary purpose is whether the thickness of the coracoacromial ligament is indicative of shoulder pathologies.
- Conditions
- Shoulder Pain
- Being tested
- magnetic resonance imaging
- Keywords
- Shoulder pain, coracoacromial ligament thickness
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingDevice
magnetic resonance imaging of shoulder
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of coracoacromial ligament
magnetic resonance imaging of coracoacromial ligament
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Mar 2017
- Primary completion1 Jun 2017
- Study completion1 Aug 2017
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 crossover
- Time perspective
- Prospective
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Aydoğan, Suleyman Demirel University
- Investigators
- Çiğdem Aydoğan, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546777
- Sponsor's protocol ID
- 37
- Status last verified
- May 2018
- First submitted
- 23 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- 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 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should the Coroacromial Ligament be Evaluated in Shoulder Magnetic Resonance Imaging?
- ClinicalTrials.gov ID
- NCT03546777
- Acronym / sponsor ID
- 37
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, coracoacromial ligament thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 6 Jun 2018 (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.
In this study, it was aimed to determine the relationship between pathologic findings and coracoacromial ligament thickness in magnetic resonance imaging in shoulder pain patients.
Detailed description
The coracoacromial ligament, which is part of the coracoacromial arch, plays an important role in shoulder biomechanics, joint stability and proprioception. Age-related changes due to chronic stress and cellular impairment may contribute to thickening and stiffening of the coracoacromial ligament to rupture the rotator cuff and development of shoulder pathologies such as impingement syndrome. In this study, it was aimed to determine the relationship between pathologic findings and coracoacromial ligament thickness in magnetic resonance imaging in shoulder pain patients. Secondary purpose is whether the thickness of the coracoacromial ligament is indicative of shoulder pathologies.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with shoulder pain
Key inclusion criteria (1 listed)
- Patients aged over 15 years diagnosed with shoulder pain
Key exclusion criteria (9 listed)
- Sensation and reflexes loss in the upper extremity
- Limitation in passive shoulder movements on physical examination
- Systemic rheumatic disease
- Diabetes mellitus
- Malignant disease
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 imagingmagnetic resonance imaging of shoulder | Device | – |
Primary outcome
Thickness of coracoacromial ligament
Time frame: 1 week
magnetic resonance imaging of coracoacromial ligament
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 6 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Shoulder Pain
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Night Pain Module for Rotator Cuff-Related Shoulder Pain
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Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
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Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
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Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
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.
Çiğdem Aydoğan principal investigator
Suleyman Demirel University
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, run by Suleyman Demirel 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 9 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 6 Jun 2018. 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?
Thickness of coracoacromial ligament (time frame: 1 week). 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 6 Jun 2018.