- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05996510
Suprascapular Notch Cross-sectional Area Measured by Ultrasonography
Investigation of the Relationship Between Suprascapular Notch Cross-sectional Area Measured by Ultrasonography and Disease Activity in Subacromial Impingement Syndrome
Chronic shoulder pain is one of the most common diseases affecting the quality of life today. Although there are multiple causes, one of the most common causes is shoulder impingement syndrome.
Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions that are usually evaluated, the visualization of the Suprascapular notch is usually observed during injection. The connection between the suprascapular notch and the shoulder joint has been demonstrated in different studies.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bursa, Turkey, 16320
- Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- chronic shoulder pain
- 35-65 years
- who agreed to participate in the study
Exclusion Criteria:
- . Lymphoproliferative diseases and other neoplasms
- .Uncontrolled arterial hypertension
- Metabolic syndrome
- Uncontrolled diabetes mellitus
- Mental retardation
- Antidepressant use
- Autoimmune diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: diseased shoulder
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Shoulder ultrasound is performed using a linear ultrasound probe.
The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
Other Names:
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Active Comparator: sturdy shoulder
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Shoulder ultrasound is performed using a linear ultrasound probe.
The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Suprascapular notch cross-sectional area measurement
Time Frame: baseline
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The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Scale
Time Frame: baseline
|
Visual Analog Scale was used for pain.
Pain intensity was measured using 0-10 cm visual analogue scale (VAS).
The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
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baseline
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Shoulder Pain and Disability Index (SPADI)
Time Frame: baseline
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The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings requiring the use of the upper extremities.
The pain subscale has 5-items and the Disability subscale has 8-items.To score either version of the SPADI, the total score is calculated by averaging the pain and disability subscale scores to find a score out of 100.
On this scale, 0 represents less disability while 100 represents greatest disability
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baseline
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Collaborators and Investigators
Investigators
- Study Chair: korgün ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Study Chair: Lale altan inceoğlu, phd, Uludag University Faculty Of Medicine
- Study Chair: ugur ertem, M.D., Uludag University Faculty Of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BursaYIEAH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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