Clinical trial NCT04759027: Reliability of the Subacromial Distance Measurements With Standard Radiographic Imaging
Official title: Prospective Evaluation of the Reliability and Re-applicability of Subacromial Distance Measurement With Standard Radiographic Imaging Compared to Ultrasound Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subacromial Impingement
Rotator Cuff Tears
Keywords: x-ray
direct radiography
ultrasound
acromiohumeral distance
subacromial distance
rotator cuff
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over the age of 18 who admitted to orthopedics and traumatology outpatient clinics with a complaint of non-traumatic shoulder pain for more than two weeks or traumatic shoulder pain will be study population.

Brief summary: Patients with complaints of shoulder pain or limitation of motion, who admitted to outpatient orthopaedic clinic will be analyzed. It was planned to measure the subacromial distance using standardized both shoulder ap, true ap and outlet radiographs, and ultrasound to be performed for shoulder circumference soft tissue and muscle-tendon evaluation. The measurement made by the physical therapy and rehabilitation specialist with ultrasound will be considered to be accurate, and it was planned to evaluate the reliability of the graphy measurements by comparing this measurement with the measurements in the graphs. In addition, it was planned to evaluate the intra-observer and inter-observer compliance by re-measuring the subacromial distance on the radiograph by orthopedic doctors of three different seniority levels with an interval of one month.

Detailed description: Rotator cuff injuries are the most common injury to the shoulder girdle. Patients present to the clinic with shoulder compression at an early age and with tears in older ages. Nearly 50% of the population can be torn in advanced ages. Repetitive trauma caused by overuse is blamed for rotator cuff tears. The narrowing of the subacromial distance causes compression in the anterior, tears and enlargement of the tears by extrinsic mechanism. In addition, the surgery to be performed according to the subacromial distance and the benefit to the patient from this surgery can be predicted. In studies conducted in normal population, subacromial distance was reported to be between 6-12 mm, measurements made under 6-7 mm were evaluated as pathologically and were defined as tears that would not benefit from repair.

The reliability of this measurement, which guides the diagnosis and treatment, is important. The diagnosis of these diseases is made by imaging methods following the physical examination and then the decision of the appropriate treatment method is made. It is known that conventional radiographs constitute the first step of evaluation as a standard in almost all patients in orthopedic practice. Magnetic resonance imaging and ultrasound are often preferred for shoulder, shoulder circumference pathology and injuries, in relation to the examination findings after direct radiography at the diagnosis and examination stage. Drawing graphs on both shoulders from these images to provide comparative evaluation provides more detailed information in evaluation. The subacromial distance or acromiohumeral distance used in the evaluation of rotator cuff pathologies was defined as the shortest distance between the sclerotic inferior border of the acromion and the humeral head. The measurement of this distance can be made with direct graphy, mri, ct, and ultrasound. In the only systematic review on this subject, it was emphasized that this measurement can be made with ultrasound as the most reliable, and the evaluations made by direct radiography are worthless. In these inferences, the poor methodology of the studies made using direct graphy measurement was shown as the reason. Many studies have been carried out by standardizing the imaging, its importance has been proven by the inconsistent results of the study with non-standardized graphs.

Eligibility criteria: Inclusion Criteria:

* shoulder pain ( acute traumatic or non-traumatic chronic)

Exclusion Criteria:

* end stage glenohumeral joint arthrosis
* adhesive capsulitis
* fractures
* previous shoulder surgery

Primary outcomes:
measure: RELIABILITY OF DIRECT RADIOGRAPHY IMAGING
timeFrame: within 2 weeks after first evaluation
Secondary outcomes:
measure: REPRODUCIBLITY
timeFrame: 1 month apart measurements will be evaluate
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty
Study officials:
affiliation: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
name: Mehmet F Guven, Assoc.prof
role: STUDY_DIRECTOR
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