Shoulder Motion Guided Patient Diagnostic and Treatment Classification

NCT02104531 | Completed

• 1 other identifier: 1403E49122
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Shoulder Syndrome and Allied Disorders

Outcome Measures

Primary Outcomes (1)

• Rotator cuff tendon predicted disease location

  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.

  baseline

Secondary Outcomes (2)

• Shoulder Motion

  baseline

• Shoulder functional status

  baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with shoulder pain and rotator cuff disease, as well as age and gender matched controls.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Paula M Ludewig, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 4, 2014
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

US (1)