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Completed

NCT Number: NCT05641415

Finnish Imaging of Shoulder Study

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Imaging

Other

MRI and x-ray of both shoulders

Primary outcomes

  1. Shoulder Pain and Disability Index (SPADI)

    Time frame: 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.

  2. Constant -Murley Score

    Time frame: 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 outcomes

  1. Subjective Shoulder Value (SSV)

    Time frame: 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%.

  2. Pain NRS

    Time frame: 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".

  3. EQ-5D-5L

    Time frame: 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.

Other outcomes

  1. Shoulder Magnetic Resonance Imaging (MRI)

    Time frame: At baseline

    3T bilateral shoulder MRI

  2. Shoulder Radiography

    Time frame: At baseline

    Plain radiographs (three projections) of both shoulders

  3. Clinical Shoulder Examination

    Time frame: At baseline

    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

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: At baseline

    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).

  5. Pain Catastrophizing Scale (PCS)

    Time frame: At baseline

    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.

  6. Pain Self Efficacy Questionnaire (PESQ)

    Time frame: At baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Finnish Institute for Health and Welfare
  • Helsinki University Central Hospital

Registry information

Official study title

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

Acronym: FIMAGE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2022
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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