Shoulder Motion Guided Patient Diagnostic and Treatment Classification

Completed

• Conditions: Rotator Cuff Shoulder Syndrome and Allied Disorders

• Registration Number: NCT02104531
• Lead Sponsor: University of Minnesota

Brief Summary

The investigators purpose is to determine the ability of a low cost, currently available imaging technique to predict shoulder movement disorders and the location of shoulder disease based on motion analysis of subjects with known shoulder disorders.

Detailed Description

Shoulder disorders account for the second largest number of musculoskeletal cases in the United States with a large health care burden. The current standard for diagnosis of shoulder disorders is a clinical exam, visual motion assessment and in some cases, costly magnetic resonance (MR) imaging. However, specific tissue pathologies are not always accurately identified, and often not directly linked to the magnitude of dysfunction. There is a need for categorizing or sub-grouping patients based on the underlying movement dysfunctions with which they present. Video fluoroscopy is a common clinical tool that can improve the accuracy of motion analysis. The investigators are using 2-D fluoroscopy, combined with 3-D MR imaging to measure shoulder motion. From the motion analysis we can predict areas of potential soft tissue disease, and compare these to disease locations from MR imaging. The investigators hypotheses is that our motion based predicted disease locations will be significantly associated with disease locations from MR imaging.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Study Start: 2015-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Normal subjects with normal normal shoulder movement and function will be included, age and gender matched to symptomatic subjects.
• Symptomatic subjects will be included if visual shoulder movement deviates from what might be considered normal; they are experiencing shoulder pain with movement, and clinical examination is consistent with soft tissue cumulative trauma to the soft tissues (rotator cuff disease).
• Clinical MR imaging will be used to confirm rotator cuff disease, subacromial bursitis, and/or bicipital tendinitis.

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Exclusion Criteria

• Age outside the accepted range. Contraindications to radiation exposure (pregnancy or possible pregnancy, other recent substantive radiation exposures (CT scanning, treatments involving radiation). Subjects unable to move through at least 90 degrees of shoulder motion will also be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rotator cuff tendon predicted disease location	baseline	Measures will predict presence/absence of rotator cuff disease in each of the supraspinatus, infraspinatus, and subscapularis muscles (rotator cuff).; Subjects are not followed, there is no intervention. The assessment timeframe is dependent on subjects volunteering for the study and can range from 1 month to 10 years from initial onset of their condition.

Secondary Outcome Measures

Name	Time	Method
Shoulder Motion	baseline	Shoulder joint motion will be assessed as within normal limits, increased or decreased for both rotational and translational motion of the humerus.; One cross sectional timepoint assessed, subjects are not followed. Timeframe may be 1 month to 10 years from initial symptom onset.
Shoulder functional status	baseline	Subjects will complete a functional status questionaire regarding their self-reported shoulder function.; One cross sectional timepoint assessed, subjects are not followed. Timeframe may be 1 month to 10 years from initial symptom onset.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States