Finnish Imaging of Shoulder Study (FIMAGE)

Finnish Imaging of Shoulder Study on the Prevalence of Imaging Findings of the Shoulder and Their Relevance to Clinical Symptoms in the General Population.

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Rotator Cuff Tears; Glenoid Labrum Tear; Osteo Arthritis Shoulders
• Intervention / Treatment: Other: Imaging

• Study Type: Observational
• Enrollment (Actual): 603

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Population-based sample

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General population sample; 600 participants aged 40 to 75 years will be randomly selected from a nationally representative general population sample of 9,922 individuals	Other: Imaging; MRI and x-ray of both shoulders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
EQ-5D-5L	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.	At baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Magnetic Resonance Imaging (MRI)	3T bilateral shoulder MRI	At baseline
Shoulder Radiography	Plain radiographs (three projections) of both shoulders	At baseline
Clinical Shoulder Examination	The clinical examination will include measurement of height, weight, active and passive range-of-motion (ROM) of both shoulders using an inclinometer and isometric muscle strength of shoulder abduction, internal, and external rotation. In addition, we will perform special shoulder tests following a structured assessment protocol	At baseline
Hospital Anxiety and Depression Scale (HADS)	A self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. Each item is answered by the patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression (higher scores indicating a more severe disorder).	At baseline
Pain Catastrophizing Scale (PCS)	The PCS was developed to help quantify an individual's pain experience, asking about how they feel and what they think about when they are in pain. The PCS asks 13 questions on thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. PCS total scores range from 0 - 52.	At baseline
Pain Self Efficacy Questionnaire (PESQ)	The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain. High scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients.	At baseline

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: Helsinki University Central Hospital; Finnish Institute for Health and Welfare

Publications and helpful links

General Publications

• Ibounig T, Buchbinder R, Sillanpaa N, Ramo L, Toivonen P, Raatikainen S, Koskinen S, Harkanen T, Rissanen H, Czuba T, Paavola M, Jarvinen T, Taimela S; FIMAGE investigators. Concordance of shoulder symptoms and imaging findings: a protocol for the Finnish Imaging of Shoulder (FIMAGE) study. BMJ Open. 2023 Dec 28;13(12):e074457. doi: 10.1136/bmjopen-2023-074457.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Imaging; Prevalence; Shoulder; Asymptomatic; Clinical Examination; General population; Shoulder Function
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Osteoarthritis; Rotator Cuff Injuries; Shoulder Pain
• Other Study ID Numbers: HUS/13564/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No