Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Shoulder Motion Guided Patient Diagnostic and Treatment Classification

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104531
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Rotator Cuff Shoulder Syndrome and Allied 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Shoulder Motion Guided Patient Diagnostic and Treatment Classification
Study Start Date : December 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

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



Primary Outcome Measures :
  1. Rotator cuff tendon predicted disease location [ Time Frame: 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 :
  1. Shoulder Motion [ Time Frame: 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.


  2. Shoulder functional status [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with shoulder pain and rotator cuff disease, as well as age and gender matched controls.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104531


Locations
Layout table for location information
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: Paula M Ludewig, PhD University of Minnesota

Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02104531    
Other Study ID Numbers: 1403E49122
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019