NCT02242630

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Keesler Air Force Base Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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).

Conditions

• Subacromial Bursitis
• Shoulder Pain

Interventions

Type	Name	Description
DRUG	Methylprednisolone, 20 mg	Compared with intrabursal triamcinolone
DRUG	Methylprednisolone, 40 mg	Compared with intrabursal triamcinolone
DRUG	Triamcinolone, 20 mg	Compared with methylprednisolone
DRUG	Triamcinolone, 40 mg	Compared with methylprednisolone

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-09-17
• Last updated: 2016-12-14
• Results posted: 2016-12-14

Locations

1 site across 1 country: United States