Clinical trial NCT02104531: Shoulder Motion Guided Patient Diagnostic and Treatment Classification
Official title: Shoulder Motion Guided Patient Diagnostic and Treatment Classification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Shoulder Syndrome and Allied Disorders
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with shoulder pain and rotator cuff disease, as well as age and gender matched controls.

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.

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.

Primary outcomes:
measure: Rotator cuff tendon predicted disease location
timeFrame: baseline
Secondary outcomes:
measure: Shoulder Motion
timeFrame: baseline
measure: Shoulder functional status
timeFrame: baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Paula M Ludewig, PhD
role: PRINCIPAL_INVESTIGATOR
References: