NCT00743600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

7.3 years

First QC Date

August 27, 2008

Last Update Submit

November 8, 2016

Conditions

Shoulder Pain

Keywords

ultrasoundrotator cuff

Outcome Measures

Primary Outcomes (1)

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

    1 year

Study Arms (2)

1

EXPERIMENTAL

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

Other: ultrasound of painful shoulder

2

ACTIVE COMPARATOR

healthy volunteers who do not have shoulder pain

Other: ultrasound

Interventions

ultrasound of painful shoulderOTHER

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.

1
ultrasoundOTHER

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Yoav Morag, MD

    UM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 29, 2008

Study Start

September 1, 2005

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

November 9, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

US(1)