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

NCT03182127 | Unknown

• 1 other identifier: MRI IN ELBOW JOINT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Elbow Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with non-traumatic painful elbow is diagnosed by MRI Using sensitivity, specificity and accuracy tests which used for .

  :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

Study Arms (1)

one Group

OTHER

Magnetic resonance imaging and ultrasound will be done for all patient

Radiation: Magnetic resonance imaging; Device: Ultrasound

Interventions

Magnetic resonance imaging RADIATION

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; .

one Group

Ultrasound DEVICE

ultrasound is performed by patient in supine or setting position,applied superficial probe , 2D image and color doppler if indicated.

one Group

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Recent acute traumatic cases.
• 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).
• Pregnancy and breast milk feeding.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut

Assiut,Egypt, Egypt

Location

Related Publications (1)

• Read PJ, Morrison WB. Imaging Injuries in Throwing Sports Beyond the Typical Shoulder and Elbow Pathologies. Radiol Clin North Am. 2016 Sep;54(5):857-64. doi: 10.1016/j.rcl.2016.05.001.

  PMID: 27545424 BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Ultrasonography

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sara Gamal, Residant

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Abo-elhamed, Professor,MD

CONTACT

00201001980793; dr.eman_08@yahoo.com

Omran Khodary, Lecture

CONTACT

00201117298484; Omranshow@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 9, 2017
• Study Start: January 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

EG (1)