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Finnish Imaging of Shoulder Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05641415
Acronym
FIMAGE
Enrollment
603
Registered
2022-12-07
Start date
2023-02-16
Completion date
2024-03-30
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glenoid Labrum Tear, Osteo Arthritis Shoulders, Rotator Cuff Tears, Shoulder Pain

Keywords

Prevalence, Imaging, Shoulder, Clinical Examination, Asymptomatic, General population, Shoulder Function

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.

Interventions

OTHERImaging

MRI and x-ray of both shoulders

Sponsors

Finnish Institute for Health and Welfare
CollaboratorOTHER_GOV
Helsinki University Central Hospital
CollaboratorOTHER
University of Helsinki
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Pain and Disability Index (SPADI)At baselinePatient 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 ScoreAt baselineThe 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

MeasureTime frameDescription
Subjective Shoulder Value (SSV)At baselineThe 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%.
Pain NRSAt baselineThe 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-5LAt baselineEQ-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.

Other

MeasureTime frameDescription
Shoulder Magnetic Resonance Imaging (MRI)At baseline3T bilateral shoulder MRI
Pain Self Efficacy Questionnaire (PESQ)At baselineThe 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.
Shoulder RadiographyAt baselinePlain radiographs (three projections) of both shoulders
Clinical Shoulder ExaminationAt baselineThe 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
Hospital Anxiety and Depression Scale (HADS)At baselineA 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).
Pain Catastrophizing Scale (PCS)At baselineThe 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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026