Shoulder Pain, Subacromial Bursitis
Conditions
Keywords
Subacromial bursitis, Triamcinolone, Methylprednisolone, Shoulder pain
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).
Interventions
DRUGMethylprednisolone, 20 mg
Compared with intrabursal triamcinolone
DRUGMethylprednisolone, 40 mg
Compared with intrabursal triamcinolone
DRUGTriamcinolone, 20 mg
Compared with methylprednisolone
DRUGTriamcinolone, 40 mg
Compared with methylprednisolone
Sponsors
Keesler Air Force Base Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Shoulder Function, as Measured by the QuickDASH ® | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 weeks | Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received. |
Countries
United States
Participant flow
Recruitment details
Subjects for this study were recruited from the internal medicine (IM) clinic or IM subspecialties clinic from our academic community hospital between September 2014 and December 2015. Subjects had to satisfy the inclusion criteria and have none of the exclusion criteria.
Pre-assignment details
There was no wash out, run-in, or transitions in this trial.
Participants by arm
| Arm | Count |
|---|---|
| Methylprednisolone, 20 mg Methylprednisolone, 20 mg, will be injected
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone | 15 |
| Methylprednisolone, 40 mg Methylprednisolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone | 15 |
| Triamcinolone, 20 mg Triamcinolone, 20 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 40 mg: Compared with methylprednisolone | 15 |
| Triamcinolone, 40 mg Triamcinolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone | 16 |
| Total | 61 |
Baseline characteristics
| Characteristic | Methylprednisolone, 40 mg | Triamcinolone, 20 mg | Methylprednisolone, 20 mg | Triamcinolone, 40 mg | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 8 Participants | 7 Participants | 8 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 7 Participants | 8 Participants | 8 Participants | 31 Participants |
| Age, Continuous | 69.3 years STANDARD_DEVIATION 10 | 66.9 years STANDARD_DEVIATION 12.3 | 63.0 years STANDARD_DEVIATION 10.9 | 69.0 years STANDARD_DEVIATION 9.5 | 67.1 years STANDARD_DEVIATION 10.8 |
| Gender Female | 6 Participants | 6 Participants | 10 Participants | 7 Participants | 29 Participants |
| Gender Male | 9 Participants | 9 Participants | 5 Participants | 9 Participants | 32 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 15 participants | 16 participants | 61 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 15 | 1 / 15 | 0 / 15 | 1 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 16 |
Outcome results
Primary
Change in Shoulder Function, as Measured by the QuickDASH ®
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)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Methylprednisolone, 20 mg | Change in Shoulder Function, as Measured by the QuickDASH ® | 19.2 units on a scale |
| Methylprednisolone, 40 mg | Change in Shoulder Function, as Measured by the QuickDASH ® | 21.3 units on a scale |
| Triamcinolone, 20 mg | Change in Shoulder Function, as Measured by the QuickDASH ® | 19.1 units on a scale |
| Triamcinolone, 40 mg | Change in Shoulder Function, as Measured by the QuickDASH ® | 24.7 units on a scale |
Secondary
Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Methylprednisolone, 20 mg | Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale | 1.0 units on a scale |
| Methylprednisolone, 40 mg | Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale | 1.8 units on a scale |
| Triamcinolone, 20 mg | Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale | 1.9 units on a scale |
| Triamcinolone, 40 mg | Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale | 1.8 units on a scale |
Other Pre-specified
Safety
Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.
Time frame: 6 weeks