Comparison of the Efficiency of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis

Study Overview
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Brief Summary
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It is aimed to compare in the early period the clinical and ultrasonographic findings in terms of the effectiveness of ultrasound-guided subacromial bursa injection with corticosteroid and ultrasound-guided lavage, which are the treatment options available in the literature for patients with calcific tendinitis who do not respond to conservative treatment.

Detailed Description
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Calcific tendinitis is a disease that occurs with the precipitation of hydroxyapatite crystals on tendons and shoulder region is the most involved. In the shoulder region, calcific tendinitis can involve all rotator cuff tendons, most commonly the supraspinatus. It may progress with pain and functional limitation. The pain can increase with movement or can occur at rest and sleep. The prevalence of calcific tendinitis is between 2.7% and 20% in the general population. The most common age group is between 30 and 60. It can negatively affect the family and social life of the person and cause loss of workforce. Especially in the treatment of patients with calcific tendinitis unresponsive to conservative treatment, ultrasound-guided corticosteroid injection in subacromial bursa and ultrasound-guided lavage are frequently used treatment options. However, there are very few studies in the literature comparing these two treatment methods as randomized controlled trials. In this study, it is aimed to compare the effectiveness of ultrasound guided subacromial bursa injection and ultrasound guided lavage procedures on pain scores, functional scales, disability scales, direct radiography findings and ultrasonographic imaging findings.

Official Title
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Comparison of the Efficacy of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis: A Prospective, Randomized, Double-Blind Study

Conditions
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Calcific Tendinitis, Calcific Tendinitis of Shoulder, Shoulder Pain

Intervention / Treatment
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* Procedure: Ultrasound Guided Lavage
* Procedure: Ultrasound Guided Subacromial Bursa Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases diagnosed with calcific tendinitis who did not benefit from conservative treatment Cases with calcific deposits greater than 1 cm in direct radiography, ultrasonography, or magnetic resonance imaging Cases between the ages of 18-75 whose informed consent was obtained for participation in the study Exclusion Criteria: Cases with radiculopathy ipsilateral to the affected shoulder Cases with active inflammatory arthropathy of the affected shoulder Cases with previous shoulder surgery Cases with a history of humeral head, scapula, and clavicle fractures Cases with neurological deficit affecting the upper extremity Cases with uncontrolled diabetes mellitus and uncontrolled hypertension, uncompensated congestive heart failure, chronic renal failure, chronic liver disease, tumor and/or vascular disease, inflammatory and/or infectious diseases, currently active psychiatric disease Cases with a history of subacromial bursa injection, calcific lavage or shoulder joint injection in the last 3 months Cases with a history of allergic reaction to the substance to be applied as local anesthetic Pregnancy or lactation Anticoagulant or antiagregant (antiplatelet) medication use that may interfere with the injection procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound Guided Lavage Group<br>The physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging. Patients in this group will be treated with ultrasound-guided lavage. | Procedure: Ultrasound Guided Lavage<br>* After local anesthesia of subcutaneous tissue, lavage will be performed under the guidance of ultrasound using an 18-gauge needle with injectors filled with 4 ml of saline. The needle will be advanced to the center of the calcific deposit. The injector will be kept as parallel to the ground as possible. The plunger of the injector will be pushed with a gently pressure and then released. Calcific deposits are expected to be filled into the syringe along with saline. It is predicted that the clear saline will gradually turn white and become cloudy due to the incoming calcific deposits. When the color of the liquid becomes cloudy, the syringe will be removed without moving the needle, and a new syringe containing 4 ml saline will be placed in its place. Thus, the aspirated calcific deposits will not be reinjected. The same process will be repeated with a new saline filled syringe. After the procedure, 2 ml dexamethasone and 3 ml lidocaine will be injected in subacromial bursa.<br>* Other names: Ultrasound Guided Barbotage;|
| Active Comparator: Ultrasound Guided Subacromial Bursa Injection Group<br>The physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging. Patients in this group will be treated with ultrasound-guided subacromial bursa injection with corticosteroid and lidocaine. | Procedure: Ultrasound Guided Subacromial Bursa Injection<br>* 2 ml dexamethasone and 3 ml %2 lidocaine will be injected in the subacromial bursa using a 21-gauge needle under ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Range of Motion | The change in a participant's range of motion degree as measured by a goniometer (Passive Range of Motion and Active Range of Motion) from baseline to 1 month. | Baseline, 1 month | 
| Clinical improvement measured by change in Numeric Rating Scale | A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. A patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing no pain to '10' representing worst possible pain | Baseline, 1 hour, 1 month | 
| Clinical improvement measured by change in Constant Shoulder Score | The constant shoulder score is a validated scale, measuring the shoulder function. It is an objective measurement independent of the shoulder pain. It is a 100-points scale composed of a number of individual parameters. The minimum score is 0, the maximum score is 100 points. The higher the score, the higher the quality of the function. | Baseline, 1 month | 
| Clinical improvement measured by change in Quick Dash Score | Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11 item Quick Dash questionnaire. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). | Baseline, 1 month | 
| Clinical improvement measured by change in Shoulder Disability Questionnaire | This score measures the disability of the shoulder in daily life, work, social life.0 points indicate maximum well-being, 100 points indicate maximum disability | Baseline, 1 month | 
| Change in Gartner Score of the Shoulder Calcifications on Direct Radiography | Radiological classification of calcifying tendinitis | Baseline, 1 month | 
| Change in ultrasound scoring system presented by Chiou | This score includes size, shape (arc, fragmented, nodular, cystic), power doppler activity of calcific deposits. | Baseline, 1 month | 
| Change in ultrasound classification system of calcific deposits presented by Farin | This classification includes acoustic shadowing of calcific deposits (well-defined shadow, faint shadow and no shadow) | Baseline, 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcific tendinitis, Shoulder pain, Ultrasound-guided, Lavage, Barbotage, subacromial bursa injection