Subacromial Impingement SyndromeNCT06384430
Subacromial Impingement Syndrome Functional Tests Correlation With Ultrasound Parameters
An observational study of Subacromial Impingement Syndrome and Shoulder Tendinitis, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
In this study, among the patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Muğla Training and Research Hospital and were diagnosed with subacromial impingement by anamnesis and clinical tests, inclusion criteria) and exclusion criteria will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subacromial Impingement Syndrome, Shoulder Tendinitis, Shoulder Bursitis
- What is being tested?
- Shoulder functional tests and ultrasound
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 31 Oct 2024
- How long will I take part?
- 1 Day
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Being between 18-70 years old and clinical evaluation positive for subacromial impingement syndrome.
Who may be able to join
- Being between 18-70 years old
- Clinical evaluation positive for subacromial impingement syndrome (Neer's test, Hawkins Kennedy, supraspinatus palpation test)
Who cannot join
- Under 18, over 70 years of age
- Those diagnosed with rheumatologic diseases
- Those with symptomatic shoulder osteoarthritis
- Those with shoulder instability
- Shoulder pain in active, passive cervical spine movements
- Previous shoulder surgery
Show all 9Show fewer
- Findings of adhesive capsulitis (>50% restriction of passive range of motion in 2 planes or detection of a full-thickness rotator cuff tear on ultrasound)
- Physiotherapy or intra-articular injection in the last 3 months
- Diagnosis of type 2 diabetes or hypothyroidism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mugla Egitim Arastima
Muğla
Nihal KARAYER OZGUL, 1
About this study
Official title: Subacromial Impingement Syndrome: The Relationship Between Shoulder Functional Tests and Ultrasound Parameters
In this study, among the patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Muğla Training and Research Hospital and were diagnosed with subacromial impingement by anamnesis and clinical tests, inclusion criteria) and exclusion criteria will be included in the study. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. 4 years of musculoskeletal ultrasound experience will be recorded by a radiologist using ultrasound (Siemens® V8, LA2-14A probe) in modified Crass position (positioning with the palm of the examined side on the posterior iliac wing) by measuring subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated.
Read the detailed description
Subacromial impingement syndrome is a common shoulder pain disorder. In this study, among the patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Muğla Training and Research Hospital and were diagnosed with subacromial impingement by anamnesis and clinical tests, inclusion criteria (being between 18-70 years of age, positivity for subacromial impingement syndrome in clinical evaluation (Neer's test, Hawkins Kennedy, supraspinatus palpation test)) and exclusion criteria (under 18 years of age, over 70 years of age, rheumatologic disease diagnosis, symptomatic shoulder osteoarthritis, shoulder instability; shoulder pain in active, passive cervical spine movements, previous shoulder surgery, those with adhesive capsulitis findings (>50% passive range of motion restriction in 2 planes or full-thickness rotator cuff tear detected on ultrasound), those who received physiotherapy or intra-articular injections in the last 3 months, those with type 2 diabetes or hypothyroidism) will be included in the study. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. 4 years of musculoskeletal ultrasound experience will be recorded by a radiologist using ultrasound (Siemens® V8, LA2-14A probe) in modified Crass position (positioning with the palm of the examined side on the posterior iliac wing) by measuring subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated.
- Being tested
- Shoulder functional tests and ultrasound
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder functional tests and ultrasoundDiagnostic test
On the day of the study, demographic data will be collected from patients with a clinical diagnosis of impingement and who agree to participate in the study, then DASH and Constant Murley scores will be calculated and subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio will be calculated on ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Patients with subacromial impingement syndrome | Patients with subacromial impingement syndrome: Being between 18-70 years old Clinical evaluation positive for subacromial impingement syndrome (Neer's test, Hawkins Kennedy, supraspinatus palpation test) Receives: Diagnostic Test: Shoulder functional tests and ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
subacromial bursa thickness
subacromial bursa thickness measure
Measured: 1 day
supraspinatus tendon thickness
supraspinatus tendon thickness measure
Measured: 1 day
acromiohumeral distance
acromiohumeral distance measure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Apr 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihal KARAYER OZGUL, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384430
- Sponsor's protocol ID
- MuğlaSKU-NKO
- Status last verified
- Sep 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacromial Impingement Syndrome: The Relationship Between Shoulder Functional Tests and Ultrasound Parameters
- ClinicalTrials.gov ID
- NCT06384430
- Acronym / sponsor ID
- MuğlaSKU-NKO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 25 Apr 2024 (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, among the patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Muğla Training and Research Hospital and were diagnosed with subacromial impingement by anamnesis and clinical tests, inclusion criteria) and exclusion criteria will be included in the study. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. 4 years of musculoskeletal ultrasound experience will be recorded by a radiologist using ultrasound (Siemens® V8, LA2-14A probe) in modified Crass position (positioning with the palm of the examined side on the posterior iliac wing) by measuring subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated.
Detailed description
Subacromial impingement syndrome is a common shoulder pain disorder. In this study, among the patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Muğla Training and Research Hospital and were diagnosed with subacromial impingement by anamnesis and clinical tests, inclusion criteria (being between 18-70 years of age, positivity for subacromial impingement syndrome in clinical evaluation (Neer's test, Hawkins Kennedy, supraspinatus palpation test)) and exclusion criteria (under 18 years of age, over 70 years of age, rheumatologic disease diagnosis, symptomatic shoulder osteoarthritis, shoulder instability; shoulder pain in active, passive cervical spine movements, previous shoulder surgery, those with adhesive capsulitis findings (>50% passive range of motion restriction in 2 planes or full-thickness rotator cuff tear detected on ultrasound), those who received physiotherapy or intra-articular injections in the last 3 months, those with type 2 diabetes or hypothyroidism) will be included in the study. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. 4 years of musculoskeletal ultrasound experience will be recorded by a radiologist using ultrasound (Siemens® V8, LA2-14A probe) in modified Crass position (positioning with the palm of the examined side on the posterior iliac wing) by measuring subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with subacromial impingement syndrome | – | Diagnostic Test: Shoulder functional tests and ultrasoundPatients with subacromial impingement syndrome: Being between 18-70 years old Clinical evaluation positive for subacromial impingement syndrome (Neer's test, Hawkins Kennedy, supraspinatus palpation test) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Being between 18-70 years old and clinical evaluation positive for subacromial impingement syndrome.
Key inclusion criteria (2 listed)
- Being between 18-70 years old
- Clinical evaluation positive for subacromial impingement syndrome (Neer's test, Hawkins Kennedy, supraspinatus palpation test)
Key exclusion criteria (9 listed)
- Under 18, over 70 years of age
- Those diagnosed with rheumatologic diseases
- Those with symptomatic shoulder osteoarthritis
- Those with shoulder instability
- Shoulder pain in active, passive cervical spine movements
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 |
|---|---|---|
| Shoulder functional tests and ultrasoundOn the day of the study, demographic data will be collected from patients with a clinical diagnosis of impingement and who agree to participate in the study, then DASH and Constant Murley scores will be calculated and subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio will be calculated on ultrasound. | Diagnostic test | Patients with subacromial impingement syndrome |
Primary outcome
subacromial bursa thickness
Time frame: 1 day
subacromial bursa thickness measure
supraspinatus tendon thickness
Time frame: 1 day
supraspinatus tendon thickness measure
acromiohumeral distance
Time frame: 1 day
acromiohumeral distance measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- 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.
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 Subacromial Impingement Syndrome and Shoulder Tendinitis, run by Muğla Sıtkı Koçman 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 2 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: status not confirmed, as of the sponsor's last update on 25 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nihal KARAYER OZGUL, 1 (+905073068312, nihalkarayer505@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subacromial bursa thickness (time frame: 1 day). The study lists 3 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 25 Sep 2024.