Clinical Trials Directory

Trials / Completed

CompletedNCT05272085

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Istanbul University - Cerrahpasa · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrasound Guided LavageAfter 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.
PROCEDUREUltrasound Guided Subacromial Bursa Injection2 ml dexamethasone and 3 ml %2 lidocaine will be injected in the subacromial bursa using a 21-gauge needle under ultrasound guidance.

Timeline

Start date
2022-03-09
Primary completion
2022-08-30
Completion
2022-11-30
First posted
2022-03-09
Last updated
2023-01-31

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05272085. Inclusion in this directory is not an endorsement.