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Completed

NCT Number: NCT04759027

Reliability of the Subacromial Distance Measurements With Standard Radiographic Imaging

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

subacromial distance measurement

Other

distance between acromion and humerus

Primary outcomes

  1. RELIABILITY OF DIRECT RADIOGRAPHY IMAGING

    Time frame: within 2 weeks after first evaluation

    The investigators will compare the results of subacromial distance measure on X-ray and ultrasound. Ultrasound measures were accepted as gold standart method.

Secondary outcomes

  1. REPRODUCIBLITY

    Time frame: 1 month apart measurements will be evaluate

    if X-ray measurements will correlate with ultrasound, the investigators will evaluate intraobserver and interobserver measurement differences

Sponsors and collaborators

Lead sponsor

Göker Utku değer

Other

Registry information

Official study title

Prospective Evaluation of the Reliability and Re-applicability of Subacromial Distance Measurement With Standard Radiographic Imaging Compared to Ultrasound Imaging

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 17, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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