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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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 tru
Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Current Primary Outcome: Change from baseline VAS pain score [ Time Frame: baseline and 2 weeks ]

The VAS scores for pain were obtained using a 100-mm-long horizontal line, with 0 mm on the left indicating no pain and 100 mm on the right indicating very severe pain.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the active ROM [ Time Frame: between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks ]
    The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction.
  • Change of scores of the Shoulder Pain and Disability Index (SPADI) [ Time Frame: between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks ]
    The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.
  • Change of the Shoulder Disability Questionnaire (SDQ) [ Time Frame: between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks ]
    The SDQ is a symptoms-related questionnaire containing 16 items describing common situations that may induce symptoms in patients with shoulder disorders. By responding 'yes', 'no', or 'not applicable', the final score is obtained by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst situation).
  • Change of 36-item Short-Form Health Survey (SF-36) [ Time Frame: between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks ]
    The SF-36 is a 36-item questionnaire that evaluates the quality of life. It is composed of 8 subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale has a score range of 0 to 100, with a higher score indicating better health status.Patient's evaluation of the treatment effect. Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=1, effective=2, not effective=3, worse=4, much worse=5).


Original Secondary Outcome: Same as current

Information By: Shin Kong Wu Ho-Su Memorial Hospital

Dates:
Date Received: November 18, 2014
Date Started: August 2014
Date Completion:
Last Updated: January 4, 2017
Last Verified: January 2017