Finnish Imaging of Shoulder Study

NCT05641415 | Completed

• 1 other identifier: HUS/13564/2022
• Study Type: observational
• Target: 603
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Subjective Shoulder Value (SSV)

  At baseline

• Pain NRS

  At baseline

• EQ-5D-5L

  At baseline

Other Outcomes (6)

• Shoulder Magnetic Resonance Imaging (MRI)

  At baseline

• Shoulder Radiography

  At baseline

• Clinical Shoulder Examination

  At baseline

Study Arms (1)

General population sample

600 participants aged 40 to 75 years will be randomly selected from a nationally representative general population sample of 9,922 individuals

Other: Imaging

Interventions

Imaging OTHER

MRI and x-ray of both shoulders

General population sample

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population-based sample

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Helsinki: lead
• Finnish Institute for Health and Welfare: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (1)

Helsinki University

Helsinki, Finland

Location

Related 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.

  PMID: 38154899 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Rotator Cuff Injuries

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 7, 2022
• Study Start: February 16, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)