Role of MRI in Evaluation of Non-traumatic Causes of Painful Elbow

June 9, 2017 updated by: Sara gamal mohammad, Assiut University

Role of Magnetic Resonance Imaging in Evaluation of Non-traumatic Causes of Painful Elbow Joint

• Elbow pain is any type of pain that comes from structures in the elbow joint and/or in structures adjacent to the elbow joint. elbow is a complex joint; it allows to both extension and flexion, as well as rotation hand and forearm. Since most movements are a combination of these actions, Elbow pain is often caused by overuse, but in general, elbow joint is much less prone to wear-and-tear damage than are many other joints. The causes of elbow pain are numerous. Most elbow pain is due to overuse or strain on the elbow joint components, but some causes are due to trauma, infection, and/or autoimmune processes and neoplasm. Risk factors for elbow pain are numerous and range from engaging in repetitive activities and participation in sports to those associated with infection, trauma, and rheumatoid arthritis. Other adjacent structures associated with elbow pain include the shoulder, upper arm, forearm, and wrist and hand joints.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • Health-care professionals diagnose elbow pain mainly by a patient's history and physical exam. Radiologic techniques such as X-ray ,US,CT and MRI are often used to delineate the elbow structures involved. Conventional radiography remains an essential initial test in the evaluation of the elbow and its disorders. One must be familiar with the pertinent anatomy, early developmental changes, and the biomechanics of this complex joint to appreciate subtle injury patterns and articular disorders. In some cases, radiographic imaging will point to the need for further evaluation with CT, MR, or sonographic imaging High-resolution ultrasound is well suited for evaluating the elbow. Ultrasound is growing in popularity and fast becoming another modality that the radiologist can use to help diagnose elbow pathology. ultrasound offers focused and real-time high-resolution imaging of tendons, ligaments, and nerve structures. Its advantages include the use of safe nonionizing radiation, accessibility, and cost effectiveness. Ultrasound is also useful in therapeutic guided injections for its multiplanar capability and clear visualization of major vessels and nerves.
  • MR imaging provides clinically useful information in assessing the elbow joint. Superior depiction of muscles, ligaments, and tendons as well as the ability to visualize nerves, bone marrow, and hyaline cartilage directly are advantages of MR imaging relative to conventional imaging techniques. These features of MR imaging may help to establish the cause of elbow pain by accurately depicting the presence and extent of bone and soft-tissue pathology. Ongoing improvements in surface coil design and newer pulse sequences have resulted in higher quality MR images of the elbow that can be obtained more rapidly. This is especially important in MR as the imaging tool that shows a highest soft tissue resolution among other imaging techniques. Recent clinical experience has shown the utility of MR imaging in detecting and characterizing disorders of the elbow in a a noninvasive fashion.

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.
Interventional

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.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 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.

Study Contact Backup

Study Locations

  • Egypt
      • Assiut,Egypt, Egypt
        • Assiut

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

7 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical diagnosis of elbow pain not related by trauma.
  2. Cases with self-reported history of overuse, infection, autoimmune disease, bleeding tendency and neoplasm of bone, joint, soft tissue at elbow.

Exclusion Criteria:

  1. Recent acute traumatic cases.
  2. Cases not fulfilling MRI criteria(contraindicated for MRI): metal implant (pacemaker, artificial valve prosthesis ,implantable cardiovascular defibrillator, nerve simulator, intro-ocular implant, cochlear implants, arterial clips, bullets or metal fragments, swan-guns catheter).
  3. Pregnancy and breast milk feeding.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: one Group
Magnetic resonance imaging and ultrasound will be done for all patient
Radiation: Magnetic resonance imaging
MRI of the elbow is performed in either the supine or prone position A high-resolution surface coil is essential in order to obtain high-quality images . Elbow MRI scanning protocols consist of a combination of T1-weighted and fat-suppressed T2- or proton density-weighted images obtained in the axial, coronal oblique, and sagittal oblique imaging planes. Axial images should extend from the distal humeral diaphysis to the level of the bicipital tuberosity of the radius. From the axial images, coronal oblique images should be prescribed parallel to a line drawn through the centre of the humeral epicondyles, with sagittal oblique images prescribed perpendicular to this. Additional sequences may be helpful in certain circumstances; .
Device: Ultrasound
ultrasound is performed by patient in supine or setting position,applied superficial probe , 2D image and color doppler if indicated.

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
Number of participants with non-traumatic painful elbow is diagnosed by MRI Using sensitivity, specificity and accuracy tests which used for .
Time Frame: 6 Months
:46 cases, is calculated using the Open Epi software programme, version 2.3.1. previous study reported the expected rate 40%. estimated the increase into 40% (80%). using two sided chi-square (x-2) test with alpha (95%). total sample size of at least (46) using 80% power will be needed (odd ratio=0.17). assuming a rate of drop-out of (10%), so, will include (46) cases.
6 Months

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Gamal, Residant, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 1, 2018

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.
June 1, 2018

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.
December 1, 2018

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).
June 5, 2017

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.
June 8, 2017

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.
June 9, 2017

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.
June 14, 2017

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.
June 9, 2017

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.
June 1, 2017

More Information

Terms related to this study

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.
  • MRI IN ELBOW JOINT

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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