Clinical trial NCT02242630: Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
Official title: Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Bursitis
Shoulder Pain
Keywords: Subacromial bursitis
Triamcinolone
Methylprednisolone
Shoulder pain
Lead sponsor: Keesler Air Force Base Medical Center
Sponsor class: FED
First posted: 2014-09-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Eligibility 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

Primary outcomes:
measure: Change in Shoulder Function, as Measured by the QuickDASH ®
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
timeFrame: 6 weeks
Other outcomes:
measure: Safety
timeFrame: 6 weeks
Locations:
city: Keesler AFB
country: United States
facility: Keesler Medical Center
state: Mississippi
Study officials:
affiliation: Keesler Medical Center
name: Matthew B Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carroll MB, Motley SA, Smith B, Ramsey BC, Baggett AS. Comparing Corticosteroid Preparation and Dose in the Improvement of Shoulder Function and Pain: A Randomized, Single-Blind Pilot Study. Am J Phys Med Rehabil. 2018 Jun;97(6):450-455. doi: 10.1097/PHM.0000000000000758.