Ultrasound Evaluation of the Rotator Cable and Associated Structures.

November 8, 2016 updated by: Yoav Morag, MD, University of Michigan
This study will use healthy volunteers and patients with shoulder problems (pain or impaired movement). Ultrasound will be used to image and document the appearance of both normal and abnormal shoulder structures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to document normal and abnormal appearances of various shoulder structures (rotator cable and rotator cuff).

This study will recruit healthy volunteers and patients who have been referred to Radiology for a symptomatic shoulder (a shoulder that is causing the patient pain, or is limited in its ability to move.) Both groups will undergo ultrasound imaging of the shoulder.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with shoulder pain referred to radiology for ultrasound of shoulder

Exclusion Criteria:

  • Patients less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients with shoulder pain who were clinically referred to Ultrasound for evaluation
Other: ultrasound of painful shoulder
Patients who have a shoulder that is painful or has limited movement who were referred to Radiology will have an ultrasound exam of their shoulder.
Active Comparator: 2
healthy volunteers who do not have shoulder pain
Other: ultrasound
Healthy volunteers who do not have pain or limited movement will have an ultrasound exam of their shoulder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if Ultrasound can identify the rotator cable and the associated structures.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Yoav Morag, MD, UM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

November 9, 2016

Last Update Submitted That Met QC Criteria

November 8, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM1500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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