Elbow DiseaseNCT03182127
Role of MRI in Evaluation of Non-traumatic Causes of Painful Elbow
A study testing Magnetic resonance imaging and Ultrasound in people with Elbow Disease, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Elbow Disease
- What is being tested?
- Magnetic resonance imaging and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Dec 2018
- 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 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut
Assiut,Egypt
Sara Gamal, M.B.B.CH, 001064650680, sara_gamal4011@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Elbow Disease
- Being tested
- Magnetic resonance imaging, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingRadiation
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; .
UltrasoundDevice
ultrasound is performed by patient in supine or setting position,applied superficial probe , 2D image and color doppler if indicated.
| Study group | Role | What they receive |
|---|---|---|
| one Group | Other | Magnetic resonance imaging and ultrasound will be done for all patient Receives: Radiation: Magnetic resonance imaging; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elbow DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara gamal mohammad, Assiut University
- Investigators
- Sara Gamal, Residant, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182127
- Sponsor's protocol ID
- MRI IN ELBOW JOINT
- Status last verified
- Jun 2017
- First submitted
- 5 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27545424
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Magnetic Resonance Imaging in Evaluation of Non-traumatic Causes of Painful Elbow Joint
- ClinicalTrials.gov ID
- NCT03182127
- Acronym / sponsor ID
- MRI IN ELBOW JOINT
- Conditions
- Elbow Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 9 Jun 2017 (actual)
- 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.
- 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one Group | Other | Radiation: Magnetic resonance imaging, Device: UltrasoundMagnetic resonance imaging and ultrasound will be done for all patient |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Magnetic resonance imagingMRI 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; . | Radiation | one Group |
| Ultrasoundultrasound is performed by patient in supine or setting position,applied superficial probe , 2D image and color doppler if indicated. | Device | one Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Background: PubMed 27545424Read 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.
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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.
Sara Gamal, Residant principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging and Ultrasound in people with Elbow Disease, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jun 2017. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Abo-elhamed, Professor,MD (00201001980793, dr.eman_08@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182127, which also lists 1 linked publication.
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 14 Jun 2017.