Finnish Imaging of Shoulder Study

Shoulder Pain Clinical Trial

— FIMAGE  

Official 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05641415
• Other study ID #: HUS/13564/2022
• Status: Active, not recruiting
• Start date: January 30, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 603
• Est. completion date: June 2024
• Est. primary completion date: March 31, 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

Related Conditions & MeSH terms

• Glenoid Labrum Tear
• Osteo Arthritis Shoulders
• Osteoarthritis
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Pain

Intervention

Other:
• Imaging
MRI and x-ray of both shoulders

Locations

Country	Name	City	State
Finland	Helsinki University	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
University of Helsinki	Finnish Institute for Health and Welfare, Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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

Outcome

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