Trial Outcomes & Findings for Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis (NCT NCT02242630)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

6 weeks

Results posted on

2016-12-14

Participant Flow

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.

There was no wash out, run-in, or transitions in this trial.

Participant milestones

Participant milestones
Measure	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	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	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	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
Overall Study STARTED	15	15	15	16
Overall Study COMPLETED	15	15	15	16
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methylprednisolone, 20 mg n=15 Participants 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	Methylprednisolone, 40 mg n=15 Participants 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	Triamcinolone, 20 mg n=15 Participants 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	Triamcinolone, 40 mg n=16 Participants 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	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	31 Participants n=21 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants
Age, Continuous	63.0 years STANDARD_DEVIATION 10.9 • n=5 Participants	69.3 years STANDARD_DEVIATION 10.0 • n=7 Participants	66.9 years STANDARD_DEVIATION 12.3 • n=5 Participants	69.0 years STANDARD_DEVIATION 9.5 • n=4 Participants	67.1 years STANDARD_DEVIATION 10.8 • n=21 Participants
Gender Female	10 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	29 Participants n=21 Participants
Gender Male	5 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	32 Participants n=21 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	15 participants n=5 Participants	16 participants n=4 Participants	61 participants n=21 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Methylprednisolone, 20 mg n=15 Participants 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	Methylprednisolone, 40 mg n=15 Participants 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	Triamcinolone, 20 mg n=15 Participants 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	Triamcinolone, 40 mg n=16 Participants 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
Change in Shoulder Function, as Measured by the QuickDASH ®	19.2 units on a scale Interval 7.1 to 31.4	21.3 units on a scale Interval 11.3 to 31.4	19.1 units on a scale Interval 11.8 to 26.4	24.7 units on a scale Interval 16.4 to 33.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Methylprednisolone, 20 mg n=15 Participants 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	Methylprednisolone, 40 mg n=15 Participants 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	Triamcinolone, 20 mg n=15 Participants 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	Triamcinolone, 40 mg n=16 Participants 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
Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale	1.0 units on a scale Interval 0.1 to 1.9	1.8 units on a scale Interval 0.1 to 3.5	1.9 units on a scale Interval 0.6 to 3.2	1.8 units on a scale Interval 0.4 to 3.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.

Outcome measures

Outcome data not reported

Adverse Events

Methylprednisolone, 20 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Methylprednisolone, 40 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Triamcinolone, 20 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Triamcinolone, 40 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Methylprednisolone, 20 mg n=15 participants at risk 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	Methylprednisolone, 40 mg n=15 participants at risk 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	Triamcinolone, 20 mg n=15 participants at risk 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	Triamcinolone, 40 mg n=16 participants at risk 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
Endocrine disorders Elevated blood glucose	6.7% 1/15 • Number of events 1 • 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.	6.7% 1/15 • Number of events 1 • 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.	0.00% 0/15 • 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.	6.2% 1/16 • Number of events 1 • 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.

Additional Information

Matthew B. Carroll

Keesler Medical Center

Phone: 228-376-3629

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place