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

Condition(s) targeted: Subacromial Bursitis; Shoulder Pain

Intervention: Methylprednisolone, 20 mg (Drug); Methylprednisolone, 40 mg (Drug); Triamcinolone, 20 mg (Drug); Triamcinolone, 40 mg (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Keesler Air Force Base Medical Center

Official(s) and/or principal investigator(s):
Matthew B Carroll, MD, Principal Investigator, Affiliation: Keesler Medical Center

Overall contact:
Matthew B Carroll, MD, Phone: 228-376-3629, Email: matthew.carroll.1@us.af.mil

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Improvement in shoulder function, as measured by the QuickDASH ®

Secondary outcome: Improvement in subject reported shoulder pain as measured by the Visual Analogue Scale

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 years or older

- History and physical examination consistent with shoulder pain and subacromial

bursitis

- At least 2 weeks of shoulder pain and subacromial bursitis

Exclusion Criteria:

- Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone

- History or examination suspicious for a humeral head fracture

- History or examination consistent with adhesive capsulitis (normal X-Ray of the

shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side

- History or examination consistent with acute synovitis of the glenohumeral or

acromioclavicular joint

- Any shoulder surgery involving the affected arm within the last 6 months

Matthew B Carroll, MD, Phone: 228-376-3629, Email: matthew.carroll.1@us.af.mil

Keesler Medical Center, Keesler AFB, Mississippi 39534, United States; Recruiting
Thomas Shaak, Phone: 228-376-4357, Email: thomas.shaak@us.af.mil
Matthew B Carroll, MD, Principal Investigator
Chris B Ramsey, MD, Sub-Investigator
Alan Baggett, MD, Sub-Investigator
Spencer A Motley, MD, Sub-Investigator
Benjamin Smith, MD, Sub-Investigator
Kristine Arocho, Sub-Investigator

Starting date: September 2014
Last updated: April 9, 2015