Finnish Imaging of Shoulder Trauma

Shoulder Pain Clinical Trial

— FIMAGE-T  

Official title:

Finnish Imaging of Shoulder Trauma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800184
• Other study ID #: HUS/13603/2022
• Status: Recruiting
• Start date: April 5, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: University of Helsinki
• Contact: Thomas Ibounig, MD
• Phone: +358504286223
• Email: thomas.ibounig[@]helsinki.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Eligible participants of the FIMAGE study will be invited to a follow up visit in the case of a shoulder injury or a sudden onset of significant shoulder symptoms (within a 2-year time frame). These findings will then be compared to the baseline data collected in the FIMAGE study (including the comparison of pre-injury and post-injury MRI:s)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Ambulatory
• Participated in the FIMAGE
• Baseline MRI from FIMAGE study available

Exclusion Criteria:

• Contraindications to MRI
• Previous shoulder joint replacement
• Previous rotator cuff surgery

Related Conditions & MeSH terms

• Glenoid Labrum Tear
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Injuries
• Shoulder Pain

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
University of Helsinki	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Shoulder Examination	The clinical examination will include orthopaedic shoulder tests used to assess rotator cuff integrity (internal rotation lag sign, lift off, press belly, hornblower sign, bear hug test, drop arm sign, external rotation lag sign).	At baseline
Primary	Rotator Cuff Integrity on Shoulder Magnetic Resonance Imaging (MRI)	Bilateral shoulder MRI comparing the integrity of the rotator cuff tendons on pre-injury and post-injury MRI scans. Each of the four rotator cuff tendons (supraspinatus, infraspinatus, teres minor, subscapularis) will be assessed and graded for structural changes (normal, tendinopathy, partial thickness tear, full thickness tear). The dimensions of full thickness tears will be measured and recorded (size in millimeters).	At baseline
Primary	Shoulder Pain and Disability Index (SPADI)	Patient reported outcome measure. The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. A SPADI total score ranging from 0 (best) to 100 (worst) is produced by averaging the two subscale scores.	At baseline
Primary	Constant -Murley Score	The Constant-Murley Score was designed to assess the functional state of a shoulder and contains both physician- completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).	At baseline
Secondary	Subjective Shoulder Value (SSV)	The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.	At baseline
Secondary	Pain NRS	The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".	At baseline