Clinical Trial: Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis

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

Official Title: Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone

Brief Summary: It is currently unknown whether or not the improvement in pain and function related to a "steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone significantly affect improvement in shoulder pain 6 weeks after injection.

Detailed Summary:

Background: Subacromial bursitis is a common site for patients to report shoulder pain. In some patients it is refractory to conservative therapies such as physical therapy, acetaminophen, or NSAIDs. Subacromial injection of a corticosteroid can be used to improve shoulder pain in subacromial bursitis, however, there are few well done clinical trials guiding which type of corticosteroid and the dose that would be maximally effective and with the least amount of side effects.

Methods: Our hypothesis is that both Methylprednisolone and Triamcinolone are equipotent but that 20 mg provides less relief that 40 mg injected. Subjects will be enrolled in this trial which lasts 6 weeks. Subjects will be randomized to 40 mg of methylprednisolone, 20 mg of methylprednisolone, 40 mg of triamcinolone, or 20 mg of triamcinolone. No placebo will be used as prior studies suggest that placebo with lidocaine is inferior to corticosteroid injection.

Outcomes: Primary outcome with be the improvement in a functional measure of the shoulder, the QuickDASH ®, at 6 weeks. Secondary outcomes will be improvement in reported pain (visual analogue scale) at 6 weeks and adverse events at all time points. Data will be collected in person at the time of injection and then by phone at day 3, day 21 (3 weeks), and day 42 (6 weeks).


Sponsor: Keesler Air Force Base Medical Center

Current Primary Outcome: Change in Shoulder Function, as Measured by the QuickDASH ® [ Time Frame: 6 weeks ]

The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)


Original Primary Outcome: Improvement in shoulder function, as measured by the QuickDASH ® [ Time Frame: 6 weeks ]

The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)


Current Secondary Outcome: Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale [ Time Frame: 6 weeks ]

Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.


Original Secondary Outcome: Improvement in subject reported shoulder pain as measured by the Visual Analogue Scale [ Time Frame: 6 weeks ]

Improvement in shoulder pain reported by the subject after injection at 6 weeks. The patient will indicate from 0 (no pain) to 10 (maximal pain) changes in shoulder pain after injection. A 2 point change is expected.


Information By: Keesler Air Force Base Medical Center

Dates:
Date Received: September 14, 2014
Date Started: September 2014
Date Completion:
Last Updated: October 22, 2016
Last Verified: August 2016