High Resolution Ultrasound in Evaluation of Shoulder Pain Guided by MRI

March 25, 2019 updated by: Shehab Gamal Abdallah, Assiut University

Role of High Resolution Ultrasound Imaging in Evaluation of Shoulder Pain Guided by Magnetic Resonance Imaging Findings

To asses causes of shoulder pain by Ultrasound in guide of MRI diagnosis to help Ultrasound to be used alone in the future

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

shoulder pain is a common medical condition, particularly in middle-aged and older adults, Shoulder pain makes up about 15% of all musculoskeletal complaints and has an incidence of 25 cases/1000 patients from 45-64 years old. Most shoulder problems fall into three major categories: soft tissue disorders, articular injury or instability, and arthritis. The incidence of lesions increases with age as tendon tissue progressively weakens or degenerates, but repeated microtrauma or overuse from professional or athletic activity can also cause soft tissue problems in all age groups.Patients younger than 30 yrs. old tend to have mild inflammatory or biomechanical causes for their pain such as a traumatic instability, tendinosis and arthropathy.The major cause of shoulder pain in patients older than 40 years is rotator cuff impingement and tears.There are no clear national guidelines for the diagnosis of shoulder pain. Several diagnostic tests are used for the diagnosis of soft tissue disorders, including clinical assessment, ultrasonography, magnetic resonance imaging (MRI), CT , X-ray and Arthroscopy. Shoulder pain is common, but the complexity of the shoulder joint frequently creates a diagnostic challenge for clinicians trying to identify the source of pain. As it is the most mobile joint in the body, the shoulder has a wide variety of physical exam maneuvers and tests designed to help the clinician diagnose shoulder pathology. So the current challenge from the clinicians is to understand which physical exam test(s) can provide sensitive and specific data to diagnose shoulder pathology. Evaluation of these exam maneuvers is of moderate to low quality, but still provides valuable information on how to interpret these exam results. Ultrasound , In addition to the physical exam, point-of care diagnostic musculoskeletal ultrasound has evolved as a useful and powerful tool for both diagnosis and treatment of shoulder pain, and it has many advantages like being relatively inexpensive, noninvasive and widely available.Ultrasound is increasingly being used to image many of the structures that can cause chronic shoulder pain. Ultrasound has excellent in-plane and beam-thickness spatial resolution , although the contrast resolution of many abnormalities in the shoulder is less than that with MRI, and also it is particularly useful in patients with a suspected supraspinatus or infraspinatus tendon tear, but is also helpful in the assessment of the subscapularis, acromioclavicular joint capsule and osteophytes, biceps tendon, subacromial-subdeltoid bursa, and the spinoglenoid notch. Ultrasound also allows dynamic imaging, which can be helpful when looking for biceps tendon subluxation, subscapularis tendon tears, and arm-abduction supraspinatus tendon impingement .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients have positive tests of shoulder pain by clinical examination and suspected by Plain X-ray to have shoulder instability.

Description

Inclusion Criteria:

  • Patients. have positive tests of shoulder pain by clinical examination.
  • Patients who suspected by Plain X-ray to have shoulder instability.

Exclusion Criteria:

  • Patients who previously underwent surgical intervention to shoulder joint for any reason.
  • Patients with history of fracture repaired by metal plates or screws.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ultrasound findings in shoulder pain
Time Frame: baseline
to see if the same findings found by magnetic resonance in cases of shoulder pain imaging will appear by high resolution ultrasound
baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ultrasound in shoulder pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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