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

Not Applicable

Completed

• Conditions: Calcific Tendinitis; Shoulder Pain; Calcific Tendinitis of Shoulder
• Interventions: Procedure: Ultrasound Guided Lavage; Procedure: Ultrasound Guided Subacromial Bursa Injection

• Registration Number: NCT05272085
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-02-28
• Study Start: 2022-03-09
• Study First Posted: 2022-03-09
• Primary Completion: 2022-08-30
• Study Completion: 2022-11-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Lavage Group	Ultrasound Guided Lavage	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.
Ultrasound Guided Subacromial Bursa Injection Group	Ultrasound Guided Subacromial Bursa Injection	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.

Primary Outcome Measures

Name	Time	Method
Clinical improvement measured by change in Numeric Rating Scale	Baseline, 1 hour, 1 month	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"
Clinical improvement measured by change in Shoulder Disability Questionnaire	Baseline, 1 month	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
Change in ultrasound classification system of calcific deposits presented by Farin	Baseline, 1 month	This classification includes acoustic shadowing of calcific deposits (well-defined shadow, faint shadow and no shadow)
Change of Range of Motion	Baseline, 1 month	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.
Change in Gartner Score of the Shoulder Calcifications on Direct Radiography	Baseline, 1 month	Radiological classification of calcifying tendinitis
Change in ultrasound scoring system presented by Chiou	Baseline, 1 month	This score includes size, shape (arc, fragmented, nodular, cystic), power doppler activity of calcific deposits.
Clinical improvement measured by change in Constant Shoulder Score	Baseline, 1 month	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.
Clinical improvement measured by change in Quick Dash Score	Baseline, 1 month	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).

Trial Locations

Locations (1)

Istanbul University- Cerrahpaşa; 🇹🇷 Istanbul, Turkey