Finnish Imaging of Shoulder Study

Completed

• Conditions: Glenoid Labrum Tear; Osteo Arthritis Shoulders; Shoulder Pain; Rotator Cuff Tears
• Interventions: Other: Imaging

• Registration Number: NCT05641415
• Lead Sponsor: University of Helsinki

Brief Summary

In the Finnish Imaging of Shoulder study we will recruit 600 participants from a nationally representative general population sample. Participants aged 40 to 75 years will be invited to a clinical visit that includes assessment of general health, shoulder history and symptoms, and bilateral clinical examination and shoulder imaging (both plain radiography and MRI). We aim to assess the prevalence of abnormal imaging findings in both asymptomatic and symptomatic individuals and explore possible risk factors for abnormal imaging findings and shoulder symptoms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-07
• Study Start: 2023-02-16
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 603

Inclusion Criteria

• Ambulatory
• Participation in the Health 2000 Survey
• Informed Consent

Exclusion Criteria

• Dementia
• Terminal Cancer
• Previous shoulder joint replacement
• Contraindications for MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General population sample	Imaging	600 participants aged 40 to 75 years will be randomly selected from a nationally representative general population sample of 9,922 individuals

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	At baseline	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.
Constant -Murley Score	At baseline	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).

Secondary Outcome Measures

Name	Time	Method
Pain NRS	At baseline	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".
EQ-5D-5L	At baseline	EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Subjective Shoulder Value (SSV)	At baseline	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%.

Trial Locations

Locations (1)

Helsinki University; 🇫🇮 Helsinki, Finland