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Ultrasound Evaluation of the Rotator Cable and Associated Structures.

Primary Purpose

Shoulder Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ultrasound of painful shoulder

ultrasound

About this trial

This is an interventional diagnostic trial for Shoulder Pain focused on measuring ultrasound, rotator cuff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with shoulder pain referred to radiology for ultrasound of shoulder

Exclusion Criteria:

Patients less than 18 years of age

Sites / Locations

University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Patients with shoulder pain who were clinically referred to Ultrasound for evaluation

healthy volunteers who do not have shoulder pain

Outcomes

Primary Outcome Measures

To determine if Ultrasound can identify the rotator cable and the associated structures.

Secondary Outcome Measures

Full Information

NCT ID

NCT00743600

First Posted

August 27, 2008

Last Updated

November 8, 2016

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT00743600

Brief Title

Ultrasound Evaluation of the Rotator Cable and Associated Structures.

Official Title

Ultrasound Evaluation of the Rotator Cable and Associated Structures.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain

Keywords

ultrasound, rotator cuff

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Patients with shoulder pain who were clinically referred to Ultrasound for evaluation

Arm Title

Arm Type

Active Comparator

Arm Description

healthy volunteers who do not have shoulder pain

Intervention Type

Other

Intervention Name(s)

ultrasound of painful shoulder

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

ultrasound

Intervention Description

Healthy volunteers who do not have pain or limited movement will have an ultrasound exam of their shoulder.

Primary Outcome Measure Information:

Title

To determine if Ultrasound can identify the rotator cable and the associated structures.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with shoulder pain referred to radiology for ultrasound of shoulder Exclusion Criteria: Patients less than 18 years of age

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoav Morag, MD

Organizational Affiliation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Ultrasound Evaluation of the Rotator Cable and Associated Structures.

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