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High Resolution Ultrasound in Evaluation of Shoulder Pain Guided by MRI

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ClinicalTrials.gov Identifier: NCT03891992
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Shehab Gamal Abdallah, Assiut University

Tracking Information
First Submitted Date March 15, 2019
First Posted Date March 27, 2019
Last Update Posted Date March 27, 2019
Estimated Study Start Date April 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title High Resolution Ultrasound in Evaluation of Shoulder Pain Guided by MRI
Official Title Role of High Resolution Ultrasound Imaging in Evaluation of Shoulder Pain Guided by Magnetic Resonance Imaging Findings
Brief Summary To asses causes of shoulder pain by Ultrasound in guide of MRI diagnosis to help Ultrasound to be used alone in the future
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 Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Shoulder Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 25, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shehab Abdallah 201271211611 ext 00+20 ignoored0072@gmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03891992
Other Study ID Numbers ultrasound in shoulder pain
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Shehab Gamal Abdallah, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date March 2019