Shoulder Pain Clinical Trial
— FIMAGEOfficial 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.
Verified date | June 2024 |
Source | University of Helsinki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 603 |
Est. completion date | March 30, 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Ambulatory - Participation in the Health 2000 Survey - Informed Consent Exclusion Criteria: - Dementia - Terminal Cancer - Previous shoulder joint replacement - Contraindications for MRI |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University | Helsinki |
Lead Sponsor | Collaborator |
---|---|
University of Helsinki | Finnish Institute for Health and Welfare, Helsinki University Central Hospital |
Finland,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Shoulder Magnetic Resonance Imaging (MRI) | 3T bilateral shoulder MRI | At baseline | |
Other | Shoulder Radiography | Plain radiographs (three projections) of both shoulders | At baseline | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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