Subacromial Impingement SyndromeNCT06742359
Magnetic Resonance Imaging Parameters in Patients with Subacromial Impingement Syndrome
An observational study of Subacromial Impingement Syndrome, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Shoulder pain is the third most common musculoskeletal pain complaint in the world with an incidence of 7-30%. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Imaging in impingement syndrome is usually based on different imaging modalities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2025to 30 Apr 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with subacromial impingement syndrome.
Who may be able to join
- To be between the ages of 18-65
- Shoulder pain for at least six weeks
Who cannot join
- Presence of a rheumatologic disease,
- Presence of neurological disease
- Pregnancy
- Symptomatic osteoarthritis of the shoulder, shoulder instability, pathologies of the tendon of the long head of the biceps, glenoid injuries and partial tears greater than 3 mm and full-thickness tears of the rotator cuff
- Corticosteroid, hyaluronic acid and/or PRP injection in the shoulder area within the last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul
Duygu Silte Karamanlioglu, medical doctor, 00905323074990, drduygusilte@hotmail.com
Duygu Silte Karamanlioglu
About this study
Official title: Relationship of Magnetic Resonance Imaging Parameters with Shoulder Function and Pain in Patients with Subacromial Impingement Syndrome
Shoulder pain is the third most common musculoskeletal pain complaint in the world with an incidence of 7-30%. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Imaging in impingement syndrome is usually based on different imaging modalities. X-ray, magnetic resonance imaging (MRI) and ultrasound are the most commonly used, and MRI is considered by many authors to be the most reliable imaging modality for evaluation of the rotator cuff because it allows evaluation of soft tissues as well as bony abnormalities such as subacromial osteophytes and acromioclavicular joint capsular hypertrophy. MRI allows the diagnosis of rotator cuff tears with greater interobserver reliability than ultrasound in assessing tear size, retraction and atrophy. Few studies have investigated the impact of pathologic findings on MRI on the degree of symptoms and functional impairment seen in these patients. The aim of this study was to investigate the relationship between shoulder pain and function and MRI findings in patients with subacromial impingement syndrome.
Read the detailed description
In this clinical study, 100 patients who were admitted to Fatih Sultan Mehmet Training and Research Hospital Physical Medicine and Rehabilitation outpatient clinic with shoulder pain and diagnosed with subacromial shoulder impingement by routine laboratory and imaging tests will be included in this study. Demographic data such as age, gender, body mass index, education, occupation, comorbidities, smoking, alcohol consumption will be recorded. Pain intensity will be assessed by Visual analog scale (VAS) and function will be assessed by Shoulder Pain and Disability Index (SPADI).
Pain Assessment: The VAS is a one-dimensional measure of pain intensity and is commonly used in adult populations including rheumatologic patients. It can be used horizontally or vertically. The patient marks his/her own pain on a 10 cm ruler with no pain at one end and the most severe pain at the other end. In this method, the patient is told that there are two extremes and that he/she is free to mark any point between these points.
Functional assessment: All patients will be assessed for shoulder function using the Shoulder Pain and Disability Index (SPADI) The SPADI is a self-administered questionnaire that includes two dimensions, one for pain and one for functional activities. In the pain dimension, there are five questions about the severity of an individual's pain. Eight questions assess functional activities designed to measure the degree of difficulty an individual has in performing various activities of daily living that require the use of the upper limbs. Patients are asked to place a 10 cm mark as the answer to each question.
Shoulder joint range of motion: Participants' shoulder range of motion (ROM) active and passive flexion, abduction, internal and external rotation will be examined with a goniometer.
Magnetic resonance imaging: All MRI scans will be reviewed by an independent radiologist specializing in musculoskeletal imaging who is unaware of the patients' clinical data. Each MRI scan will include at least one transverse, sagittal and coronal plane consisting of at least one T1-weighted and at least one proton density (PD) weighted or T2-weighted fat-suppressed sequence. All MRI parameters will be electronically evaluated using a PACS workstation (SimplexBT PACS, Ankara Universitesi Teknokent, Ankara, Turkey).
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Subacromial impingement syndrome, pain, function, magnetic resonance imaging
- Medical subject headings
- Shoulder Impingement Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with subacromial impingement syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain Assessment: The visual analog scale is a one-dimensional measure of pain intensity and is widely used in adult populations, including rheumatologic patients. It can be used horizontally or vertically. The patient marks their pain on a 10 cm ruler with no pain at one end and the most severe pain at the other. Patients are asked to rank their pain intensity on a 10-point scale, where 0 = no pain, 5 = moderate pain and 10 = unbearable pain. In this method, the patient is told that there are two extremes and that they are free to mark any point in between. A higher value indicates more severe pain.
Measured: 2 months
Secondary outcomes (1)
Function
Functional assessment: All groups will be assessed for shoulder function using the Shoulder Pain and Disability Index. The Shoulder Pain and Disability Index includes two dimensions, one for pain and one for functional activities. Patients are asked to describe the extent of their shoulder problems by marking a number on a scale from zero (no pain or disability) to ten (maximum pain and disability) for each item. The results from each subscale are then summed and converted into a score out of 100. A minimum score of 0 and a maximum score of 100 can be obtained. The higher the final score, the greater the shoulder pain, impairment or disability.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start31 Jan 2025 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742359
- Sponsor's protocol ID
- 24/455
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Magnetic Resonance Imaging Parameters with Shoulder Function and Pain in Patients with Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06742359
- Acronym / sponsor ID
- 24/455
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Subacromial impingement syndrome, pain, function, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 19 Dec 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.
Shoulder pain is the third most common musculoskeletal pain complaint in the world with an incidence of 7-30%. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Imaging in impingement syndrome is usually based on different imaging modalities. X-ray, magnetic resonance imaging (MRI) and ultrasound are the most commonly used, and MRI is considered by many authors to be the most reliable imaging modality for evaluation of the rotator cuff because it allows evaluation of soft tissues as well as bony abnormalities such as subacromial osteophytes and acromioclavicular joint capsular hypertrophy. MRI allows the diagnosis of rotator cuff tears with greater interobserver reliability than ultrasound in assessing tear size, retraction and atrophy. Few studies have investigated the impact of pathologic findings on MRI on the degree of symptoms and functional impairment seen in these patients. The aim of this study was to investigate the relationship between shoulder pain and function and MRI findings in patients with subacromial impingement syndrome.
Detailed description
In this clinical study, 100 patients who were admitted to Fatih Sultan Mehmet Training and Research Hospital Physical Medicine and Rehabilitation outpatient clinic with shoulder pain and diagnosed with subacromial shoulder impingement by routine laboratory and imaging tests will be included in this study. Demographic data such as age, gender, body mass index, education, occupation, comorbidities, smoking, alcohol consumption will be recorded. Pain intensity will be assessed by Visual analog scale (VAS) and function will be assessed by Shoulder Pain and Disability Index (SPADI).
Pain Assessment: The VAS is a one-dimensional measure of pain intensity and is commonly used in adult populations including rheumatologic patients. It can be used horizontally or vertically. The patient marks his/her own pain on a 10 cm ruler with no pain at one end and the most severe pain at the other end. In this method, the patient is told that there are two extremes and that he/she is free to mark any point between these points.
Functional assessment: All patients will be assessed for shoulder function using the Shoulder Pain and Disability Index (SPADI) The SPADI is a self-administered questionnaire that includes two dimensions, one for pain and one for functional activities. In the pain dimension, there are five questions about the severity of an individual's pain. Eight questions assess functional activities designed to measure the degree of difficulty an individual has in performing various activities of daily living that require the use of the upper limbs. Patients are asked to place a 10 cm mark as the answer to each question.
Shoulder joint range of motion: Participants' shoulder range of motion (ROM) active and passive flexion, abduction, internal and external rotation will be examined with a goniometer.
Magnetic resonance imaging: All MRI scans will be reviewed by an independent radiologist specializing in musculoskeletal imaging who is unaware of the patients' clinical data. Each MRI scan will include at least one transverse, sagittal and coronal plane consisting of at least one T1-weighted and at least one proton density (PD) weighted or T2-weighted fat-suppressed sequence. All MRI parameters will be electronically evaluated using a PACS workstation (SimplexBT PACS, Ankara Universitesi Teknokent, Ankara, Turkey).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with subacromial impingement syndrome | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subacromial impingement syndrome.
Key inclusion criteria (2 listed)
- To be between the ages of 18-65
- Shoulder pain for at least six weeks
Key exclusion criteria (5 listed)
- Presence of a rheumatologic disease,
- Presence of neurological disease
- Pregnancy
- Symptomatic osteoarthritis of the shoulder, shoulder instability, pathologies of the tendon of the long head of the biceps, glenoid injuries and partial tears greater than 3 mm and full-thickness tears of the rotator cuff
- Corticosteroid, hyaluronic acid and/or PRP injection in the shoulder area within the last 3 months
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
Pain
Time frame: 2 months
Pain Assessment: The visual analog scale is a one-dimensional measure of pain intensity and is widely used in adult populations, including rheumatologic patients. It can be used horizontally or vertically. The patient marks their pain on a 10 cm ruler with no pain at one end and the most severe pain at the other. Patients are asked to rank their pain intensity on a 10-point scale, where 0 = no pain, 5 = moderate pain and 10 = unbearable pain. In this method, the patient is told that there are two extremes and that they are free to mark any point in between. A higher value indicates more severe pain.
1 secondary outcome
Function
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
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, run by Fatih Sultan Mehmet Training and Research Hospital 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 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: opening soon, as of the sponsor's last update on 27 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duygu Silte Karamanlioglu, Medical doctor (00905323074990, drduygusilte@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 2 months). 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 27 Dec 2024.