NCT02702206

Effect of Ultrasound-guided Hyaluronic or Corticosteroid Injections in Patients With Chronic Subacromial Bursitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial to compare the effect of ultrasound-guided hyaluronic or corticosteroid injections in patients with chronic subacromial bursitis.

Detailed description

Chronic subacromial bursitis (SAB) is a common shoulder disorder characterized by chronic shoulder pain with a painful arc of motion, which commonly occurs during abduction and sometimes during internal rotation of the shoulder. In addition, the extremes of all passive movements are painful. The range of motion (ROM) of the shoulder is usually not limited or is limited in a non-capsular pattern (mainly abduction and internal rotation). All resisted movements are painless or equally painful, and there is also tenderness over the deltoid region. The diagnosis of SAB remains doubtful until it is confirmed by an infiltration with local anesthetic. The injections can be performed by palpation (using anatomical landmarks to place the needle) or with ultrasound (US) guidance (with visualization of the needle tip at the target location). The chief advantage of an ultrasound-guided intervention is the ability to use real-time, dynamic imaging without ionizing radiation. Previous studies have demonstrated that ultrasound-guided injection ensures correct needle placement and delivery of the medicine to the target, and improved clinical outcomes with ultrasound-guided subacromial-subdeltoid (SASD) corticosteroid injections. Although SASD corticosteroid injections has been proven effective in treatment of chronic subacromial bursitis, in clinical practice, some patients fear the side effects of the corticosteroids. In the last few years, hyaluronic acid (HA) injection has been used for treatment of different kinds of shoulder disorders, including subacromial impingement syndrome, frozen shoulder, and rotator cuff tears, with variable results. However, treatment of chronic SAB with hyaluronic acid has never been reported before. Besides, some authors used combination of normal saline and lidocain as the placebo, which might not be a true placebo because lidocain can be an active medicine. Therefore, the purpose of this study is to compare the effectiveness of SASD corticosteroid, HA, and normal saline injection in treatment of patients with chronic SAB.

Conditions

• Shoulder Pain
• Subdeltoid Bursitis
• Subacromial Bursitis

Interventions

Type	Name	Description
DRUG	corticosteroids	under US guidance, 2ml triamcinolone (1ml/10mg), 0.5ml distilled water and 1ml 1% lidocaine
DRUG	hyaluronic acid	under US guidance, 2.5ml HA (ARTZ, 1% sodium hyaluronate solution, 10mg/mL, molecular weight 0.9x106Da) and 1ml 1% lidocaine
DRUG	normal saline	under US guidance, 2.5ml normal saline (placebo group). 0.5ml distilled water and 1ml 1% lidocaine

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2016-03-08
• Last updated: 2020-12-23

Locations

1 site across 1 country: Taiwan