Finnish Imaging of Shoulder Trauma (FIMAGE-T)

April 14, 2023 updated by: Professor Teppo Järvinen, University of Helsinki
The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Eligible participants of the FIMAGE study will be invited to a follow up visit in the case of a shoulder injury or a sudden onset of significant shoulder symptoms (within a 2-year time frame). These findings will then be compared to the baseline data collected in the FIMAGE study (including the comparison of pre-injury and post-injury MRI:s)

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Helsinki, Finland
      • Kuopio, Finland
        • Not yet recruiting
        • Kuopio University Hospital
        • Contact:
          • Thomas Ibounig
        • Contact:
          • Saara Raatikainen
      • Tampere, Finland, 33520
        • Not yet recruiting
        • Tampere University Hospital
        • Contact:
          • Thomas Ibounig
        • Contact:
          • Saara Raatikainen
      • Turku, Finland
        • Not yet recruiting
        • Turku University Hospital
        • Contact:
          • Thomas Ibounig
        • Contact:
          • Saara Raatikainen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects from a population based sample (FIMAGE study participants) who sustain a shoulder injury or sudden onset of significant shoulder symptoms within 2 years after the FIMAGE research visit.

Description

Inclusion Criteria:

  • Ambulatory
  • Participated in the FIMAGE
  • Baseline MRI from FIMAGE study available

Exclusion Criteria:

  • Contraindications to MRI
  • Previous shoulder joint replacement
  • Previous rotator cuff surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Individuals with a shoulder injury
Individuals from a population based sample of 600 individuals aged 40 to 75 years that sustain a shoulder injury or a sudden onset of significant shoulder symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rotator Cuff Integrity on Shoulder Magnetic Resonance Imaging (MRI)
Time Frame: At baseline
Bilateral shoulder MRI comparing the integrity of the rotator cuff tendons on pre-injury and post-injury MRI scans. Each of the four rotator cuff tendons (supraspinatus, infraspinatus, teres minor, subscapularis) will be assessed and graded for structural changes (normal, tendinopathy, partial thickness tear, full thickness tear). The dimensions of full thickness tears will be measured and recorded (size in millimeters).
At baseline
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.
At baseline
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).
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
At baseline
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".
At baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Shoulder Examination
Time Frame: At baseline
The clinical examination will include orthopaedic shoulder tests used to assess rotator cuff integrity (internal rotation lag sign, lift off, press belly, hornblower sign, bear hug test, drop arm sign, external rotation lag sign).
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 5, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/13603/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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