Impingement ShoulderNCT06665139
the Thickness of the Muscles and Pain in Impingement Syndrome
An observational study of Impingement Shoulder and Impingement Syndrome, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pain intensity will be measured with visual analog scale. Sonographic severity grade of shoulder impingement syndrome, serratus anterior muscle, upper trapezius and middle trapezius will be measured with USG in patients diagnosed with impingement and meeting the criteria and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Impingement Shoulder, Impingement Syndrome, Pain, Shoulder
- What is being tested?
- muscle thickness
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Jan 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with impingement and meeting the criteria will be included, while the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease.
Who may be able to join
- 18-65 years
- Cognitive ability to understand test instructions
- Symptom duration longer than 1 month
- At least two positive Neer, Hawkins and painful arch tests
- for healty volunteers
- 18-65 years
- cognitive ability to understand test instructions
- negative impingment test
Who cannot join
- Fibromyalgia
- cervical radiculopathy
- those who have received injections or physical therapy in the last month
- Those with a disorder that may affect shoulder joint range of motion and muscle mass (previous fracture, surgery, subluxation)
- BMI over 35
- inflammatory disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cansın Medin Ceylan
Istanbul, Bahcelievler, 34147
About this study
Official title: The Relationship Between the Thickness of the Muscles Stabilizing the Scapula and Pain in Impingement Syndrome
Pain intensity will be measured with visual analog scale. Sonographic severity grade of shoulder impingement syndrome, serratus anterior muscle, upper trapezius and middle trapezius will be measured with USG in patients diagnosed with impingement and meeting the criteria and healthy volunteers.
Read the detailed description
Patients diagnosed with impingement and meeting the criteria will be included, while the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease. Pain intensity will be measured with VAS (visual analog scale), the sonographic severity grade of shoulder impingement syndrome, the serratus anterior muscle, the upper trapezius and the middle trapezius will be measured with USG.
- Conditions
- Impingement Shoulder, Impingement Syndrome, Pain, Shoulder
- Being tested
- muscle thickness
- 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.
muscle thicknessDiagnostic test
Pain intensity will be measured with visual analog scale, sonographic severity grade of shoulder impingement syndrome, muscle thickness of serratus anterior muscle, upper trapezius and middle trapezius with USG in patients diagnosed with impingement and meeting the criteria and healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| impigment | Patients diagnosed with impingement and meeting the criteria will be included, Receives: Diagnostic Test: muscle thickness | |
| healty | the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease. Receives: Diagnostic Test: muscle thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
sonographic severity grade of shoulder impingment syndrome
The distance between the acromion and the greater tuberosity will be measured in both neutral and dynamic positions, and the disease severity will be assessed according to the ratio between these two data.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impingement ShoulderStudies 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
- Other
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cansin Medin, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- cansın medin ceylan, MD, Principal investigator, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665139
- Sponsor's protocol ID
- 2024/50
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 30 Oct 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 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Thickness of the Muscles Stabilizing the Scapula and Pain in Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06665139
- Acronym / sponsor ID
- 2024/50
- Conditions
- Impingement Shoulder, Impingement Syndrome, Pain, Shoulder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 30 Oct 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.
Pain intensity will be measured with visual analog scale. Sonographic severity grade of shoulder impingement syndrome, serratus anterior muscle, upper trapezius and middle trapezius will be measured with USG in patients diagnosed with impingement and meeting the criteria and healthy volunteers.
Detailed description
Patients diagnosed with impingement and meeting the criteria will be included, while the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease. Pain intensity will be measured with VAS (visual analog scale), the sonographic severity grade of shoulder impingement syndrome, the serratus anterior muscle, the upper trapezius and the middle trapezius will be measured with USG.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| impigment | – | Diagnostic Test: muscle thicknessPatients diagnosed with impingement and meeting the criteria will be included, |
| healty | – | Diagnostic Test: muscle thicknessthe healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with impingement and meeting the criteria will be included, while the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease.
Key inclusion criteria (8 listed)
- 18-65 years
- Cognitive ability to understand test instructions
- Symptom duration longer than 1 month
- At least two positive Neer, Hawkins and painful arch tests
- for healty volunteers
Key exclusion criteria (6 listed)
- Fibromyalgia
- cervical radiculopathy
- those who have received injections or physical therapy in the last month
- Those with a disorder that may affect shoulder joint range of motion and muscle mass (previous fracture, surgery, subluxation)
- BMI over 35
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 |
|---|---|---|
| muscle thicknessPain intensity will be measured with visual analog scale, sonographic severity grade of shoulder impingement syndrome, muscle thickness of serratus anterior muscle, upper trapezius and middle trapezius with USG in patients diagnosed with impingement and meeting the criteria and healthy volunteers. | Diagnostic test | healty, impigment |
Primary outcome
sonographic severity grade of shoulder impingment syndrome
Time frame: baseline
The distance between the acromion and the greater tuberosity will be measured in both neutral and dynamic positions, and the disease severity will be assessed according to the ratio between these two data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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Natural History of Shoulder Pathology in Manual Wheelchair Users
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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.
cansın medin ceylan, MD principal investigator
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
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 Impingement Shoulder and Impingement Syndrome, run by Istanbul Physical Medicine Rehabilitation 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 8 inclusion and 6 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 30 Oct 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?
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?
sonographic severity grade of shoulder impingment syndrome (time frame: baseline). 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 30 Oct 2024.