An observational study in Shoulder Pain, Rotator Cuff Tears and Glenoid Labrum Tear, sponsored by University of Helsinki. Completed at 1 site in Finland. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by University of Helsinki · Observational
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 603 is above the median of 82 across 130 observational studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Population-based sample
Exclusion Criteria:
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
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.
Time frame: 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).
Time frame: At baseline
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%.
Time frame: 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".
Time frame: 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.
Time frame: At baseline
Shoulder Magnetic Resonance Imaging (MRI)
3T bilateral shoulder MRI
Time frame: At baseline
Shoulder Radiography
Plain radiographs (three projections) of both shoulders
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At baseline
Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Helsinki