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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182127
Recruitment Status : Unknown
Verified June 2017 by Sara gamal mohammad, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : June 9, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sara gamal mohammad, Assiut University

Brief Summary:
• 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.

Condition or disease Intervention/treatment Phase
Elbow Disease Radiation: Magnetic resonance imaging Device: Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Magnetic Resonance Imaging in Evaluation of Non-traumatic Causes of Painful Elbow Joint
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   7 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182127


Contacts
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Contact: Eman Abo-elhamed, Professor,MD 00201001980793 dr.eman_08@yahoo.com
Contact: Omran Khodary, Lecture 00201117298484 Omranshow@yahoo.com

Locations
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Egypt
Assiut
Assiut,Egypt, Egypt
Contact: Sara Gamal, M.B.B.CH    001064650680    sara_gamal4011@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Sara Gamal, Residant Assiut University
Publications:
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Responsible Party: Sara gamal mohammad, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03182127    
Other Study ID Numbers: MRI IN ELBOW JOINT
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No