Shoulder PainNCT00743600
Ultrasound Evaluation of the Rotator Cable and Associated Structures.
A study testing ultrasound of painful shoulder and ultrasound in people with Shoulder Pain, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- ultrasound of painful shoulder and ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with shoulder pain referred to radiology for ultrasound of shoulder
Who cannot join
- Patients less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48105
About this study
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.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- ultrasound of painful shoulder, ultrasound
- Keywords
- ultrasound, rotator cuff
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ultrasoundOther
Healthy volunteers who do not have pain or limited movement will have an ultrasound exam of their shoulder.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with shoulder pain who were clinically referred to Ultrasound for evaluation Receives: Other: ultrasound of painful shoulder |
| 2 | Active comparator | healthy volunteers who do not have shoulder pain Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if Ultrasound can identify the rotator cable and the associated structures.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startSep 2005
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoav Morag, MD, University of Michigan
- Investigators
- Yoav Morag, MD, Principal investigator, UM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743600
- Sponsor's protocol ID
- HUM1500
- Status last verified
- Nov 2016
- First submitted
- 27 Aug 2008
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of the Rotator Cable and Associated Structures.
- ClinicalTrials.gov ID
- NCT00743600
- Acronym / sponsor ID
- HUM1500
- Conditions
- Shoulder Pain
- Keywords
- ultrasound, rotator cuff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: ultrasound of painful shoulderPatients with shoulder pain who were clinically referred to Ultrasound for evaluation |
| 2 | Active comparator | Other: ultrasoundhealthy volunteers who do not have shoulder pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with shoulder pain referred to radiology for ultrasound of shoulder
Key exclusion criteria (1 listed)
- Patients less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound of painful shoulderPatients who have a shoulder that is painful or has limited movement who were referred to Radiology will have an ultrasound exam of their shoulder. | Other | 1 |
| ultrasoundHealthy volunteers who do not have pain or limited movement will have an ultrasound exam of their shoulder. | Other | 2 |
Primary outcome
To determine if Ultrasound can identify the rotator cable and the associated structures.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoav Morag, MD principal investigator
UM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound of painful shoulder and ultrasound in people with Shoulder Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if Ultrasound can identify the rotator cable and the associated structures. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.