Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | September 2016 |
| Contact: | Matthew B Carroll, MD |
| Email: | matthew.carroll.1@us.af.mil |
| Phone: | 228-376-3629 |
Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone
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.
"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.
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).
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).
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
We found this trial at
1
site
Keesler AFB, Mississippi 39534
Principal Investigator: Matthew B Carroll, MD
Phone: 228-376-4357
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