Comparison of the Efficacy of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis: A Prospective, Randomized, Double-Blind Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Calcific Tendinitis
- Sponsor
- Istanbul University - Cerrahpasa (IUC)
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Clinical improvement measured by change in Numeric Rating Scale
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Nuri Tugbay Yildiran
Principal Investigator
Istanbul University - Cerrahpasa (IUC)
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Clinical improvement measured by change in Numeric Rating Scale
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, 1 month
This classification includes acoustic shadowing of calcific deposits (well-defined shadow, faint shadow and no shadow)
Change of Range of Motion
Time Frame: 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
Time Frame: Baseline, 1 month
Radiological classification of calcifying tendinitis
Change in ultrasound scoring system presented by Chiou
Time Frame: 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
Time Frame: 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
Time Frame: 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).