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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06384430
Other study ID # MuglaSKU-NKO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date September 1, 2024

Study information

Verified date May 2024
Source Mugla Sitki Koçman University
Contact Nihal KARAYER OZGUL, 1
Phone +905073068312
Email nihalkarayer505@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date September 1, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Being between 18-70 years old 2. Clinical evaluation positive for subacromial impingement syndrome (Neer's test, Hawkins Kennedy, supraspinatus palpation test) Exclusion Criteria: 1. Under 18, over 70 years of age 2. Those diagnosed with rheumatologic diseases 3. Those with symptomatic shoulder osteoarthritis 4. Those with shoulder instability 5. Shoulder pain in active, passive cervical spine movements 6. Previous shoulder surgery 7. 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) 8. Physiotherapy or intra-articular injection in the last 3 months 9. Diagnosis of type 2 diabetes or hypothyroidism

Study Design


Intervention

Diagnostic Test:
Shoulder functional tests and ultrasound
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.

Locations

Country Name City State
Turkey Mugla Egitim Arastima Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary subacromial bursa thickness subacromial bursa thickness measure 1 day
Primary supraspinatus tendon thickness supraspinatus tendon thickness measure 1 day
Primary acromiohumeral distance acromiohumeral distance measure 1 day
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