Trial Outcomes & Findings for Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain (NCT NCT00597766)

Last Updated: 2017-12-13

Results Overview

Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)

Results posted on

2017-12-13

Participant Flow

Subjects were recruited from an urban, academic rehabilitation center from 10/2007 to 6/2012 in the United States.

Subjects had to have a positive Neer's test (50% pain reduction by subacromial lidocaine) to be enrolled and randomized. 59 were screened. 28 subjects were consented and enrolled.

Participant milestones

Participant milestones
Measure	20mg Triamcinolone Low dose group.	40mg Triamcinolone Standard dose group	60mg Triamcinolone High dose group
Enrolled STARTED	9	9	10
Enrolled COMPLETED	9	9	10
Enrolled NOT COMPLETED	0	0	0
Follow-up 1, Week 4 STARTED	9	9	10
Follow-up 1, Week 4 COMPLETED	8	9	10
Follow-up 1, Week 4 NOT COMPLETED	1	0	0
Follow-up 2, Week 8 STARTED	8	9	10
Follow-up 2, Week 8 COMPLETED	8	9	9
Follow-up 2, Week 8 NOT COMPLETED	0	0	1
Follow-up 3, Week 12 STARTED	8	9	9
Follow-up 3, Week 12 COMPLETED	8	9	9
Follow-up 3, Week 12 NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	20mg Triamcinolone Low dose group.	40mg Triamcinolone Standard dose group	60mg Triamcinolone High dose group
Follow-up 1, Week 4 Withdrawal by Subject	1	0	0
Follow-up 2, Week 8 Lost to Follow-up	0	0	1

Baseline Characteristics

Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20mg Triamcinolone n=9 Participants Low dose group.	40mg Triamcinolone n=9 Participants Standard dose group	60mg Triamcinolone n=10 Participants High dose group	Total n=28 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
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Age, Continuous	58.3 years STANDARD_DEVIATION 7.1 • n=5 Participants	54.7 years STANDARD_DEVIATION 10.2 • n=7 Participants	54.0 years STANDARD_DEVIATION 9.9 • n=5 Participants	55.6 years STANDARD_DEVIATION 9.1 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	10 participants n=5 Participants	28 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)

Population: We used available-cases. Missing values handled with maximum likelihood methods.

Outcome measures

Outcome measures
Measure	20mg Triamcinolone n=9 Participants Low dose group.	40mg Triamcinolone n=9 Participants Standard dose group	60mg Triamcinolone n=10 Participants High dose group
BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire	-1.7 units on a scale Interval -3.9 to 0.6	-2.2 units on a scale Interval -4.4 to 0.0	-4.7 units on a scale Interval -6.8 to -2.5

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12 (4 times)

Population: Available-case analysis with missing data handled by maximum likelihood methods.

Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale: 0 = cannot perform 1. = performs partially 2. = performs fully Scores for 33 motor function items are summed to arrive at a total score ranging from 0 to 66, where higher scores indicate greater motor function Differences baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.

Outcome measures

Outcome measures
Measure	20mg Triamcinolone n=9 Participants Low dose group.	40mg Triamcinolone n=9 Participants Standard dose group	60mg Triamcinolone n=10 Participants High dose group
Fugl-Meyer Motor Assessment, Upper Limb Domain	5.1 units on a scale Interval -0.1 to 10.4	4.5 units on a scale Interval -0.9 to 9.8	2.3 units on a scale Interval -2.8 to 7.4

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12 (4 times)

Population: Available-case analysis with missing data handled by maximum likelihood methods.

Differences in least-mean squares (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.

Outcome measures

Outcome measures
Measure	20mg Triamcinolone n=9 Participants Low dose group.	40mg Triamcinolone n=9 Participants Standard dose group	60mg Triamcinolone n=10 Participants High dose group
Pain Free External Rotation Range of Motion (ROM)	26.7 units on a scale Interval 8.2 to 45.1	12.7 units on a scale Interval -6.0 to 31.4	10.3 units on a scale Interval -7.5 to 28.1

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12 (4 times)

Population: Available-case analysis with missing data handled by maximum likelihood methods.

Difference in least-squares means (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.

Outcome measures

Outcome measures
Measure	20mg Triamcinolone n=9 Participants Low dose group.	40mg Triamcinolone n=9 Participants Standard dose group	60mg Triamcinolone n=10 Participants High dose group
Pain Free Abduction Range of Motion (ROM)	33.3 units on a scale Interval 7.9 to 58.7	15.2 units on a scale Interval -10.6 to 41.0	28.0 units on a scale Interval 3.3 to 52.6

Adverse Events

20mg Triamcinolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

40mg Triamcinolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

60mg Triamcinolone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	20mg Triamcinolone n=9 participants at risk Low dose group.	40mg Triamcinolone n=9 participants at risk Standard dose group	60mg Triamcinolone n=10 participants at risk High dose group
Gastrointestinal disorders GI Illness requiring hospitalization	0.00% 0/9	0.00% 0/9	10.0% 1/10 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard Wilson

MetroHealth Medical Center

Phone: 216-957-3529

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place