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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone, 20 mg | Active Comparator | Methylprednisolone, 20 mg, will be injected |
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| Methylprednisolone, 40 mg | Active Comparator | Methylprednisolone, 40 mg, will be injected |
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| Triamcinolone, 20 mg | Active Comparator | Triamcinolone, 20 mg, will be injected |
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| Triamcinolone, 40 mg | Active Comparator | Triamcinolone, 40 mg, will be injected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone, 20 mg | Drug | Compared with intrabursal triamcinolone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received. | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew B Carroll, MD | Keesler Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keesler Medical Center | Keesler Air Force Base | Mississippi | 39534 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28609319 | Derived | 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. |
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No plan to release IPD to other researchers
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There was no wash out, run-in, or transitions in this trial.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Methylprednisolone, 40 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Methylprednisolone, 40 mg | Drug | Compared with intrabursal triamcinolone |
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| Triamcinolone, 20 mg | Drug | Compared with methylprednisolone |
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| Triamcinolone, 40 mg | Drug | Compared with methylprednisolone |
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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 |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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Fifteen subjects were enrolled in each arm except for the TAC40 arm which had 16. The average age of the cohort was 67.1 ± 10.8 years old.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 6 weeks |
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| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 weeks |
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| Other Pre-specified | Safety | Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received. | Not Posted | 6 weeks | Participants |
Data regarding adverse events were collected for the 6 weeks that subjects were followed in this trial, with subjects queried about adverse events at the time of injection, 3 days after injection, 3 weeks, and 6 weeks after injection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 15 | 1 | 15 | ||
| EG001 | 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 | 0 | 15 | 1 | 15 | ||
| EG002 | 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 | 0 | 15 | 0 | 15 | ||
| EG003 | 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 | 0 | 16 | 1 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated blood glucose | Endocrine disorders | Non-systematic Assessment | Increase in blood glucose as measured by participant which would be considered by the participant as beyond their normal range |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew B. Carroll | Keesler Medical Center | 228-376-3629 | matthew.carroll.1@us.af.mil |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| D008776 | Methylprednisolone Hemisuccinate |
| D014221 | Triamcinolone |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| 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 |
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