Shoulder Motion Guided Patient Diagnostic and Treatment Classification

NCT ID: NCT02104531

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-12-31

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.

Conditions

Rotator Cuff Shoulder Syndrome and Allied Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Shoulder Pain

No intervention. Subjects will have a standard static MRI taken of their shoulder, and also complete a series of shoulder motions using video fluoroscopy.

No interventions assigned to this group

Healthy Subjects

No intervention. Subjects will receive a standard shoulder MRI and perform shoulder motions while being measured with video fluoroscopy.

No interventions assigned to this group

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paula M Ludewig, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1403E49122

Identifier Type: -

Identifier Source: org_study_id