Trial Outcomes & Findings for Pain Increases After Shoulder Injection (NCT NCT05438277)
NCT ID: NCT05438277
Last Updated: 2023-03-07
Results Overview
A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain.
COMPLETED
PHASE4
421 participants
Post-injection day 1 through 7
2023-03-07
Participant Flow
421 patients were enrolled in the study. Out of these 421, 15 patients received bilateral shoulder injections. Thus, there were 436 total shoulders injected. The term used in the study to refer to the number of shoulders injected, rather than the number of patients, is "person-visits."
Unit of analysis: Person-visits
Participant milestones
| Measure |
Methylprednisolone Acetate (MPA)
subacromial or glenohumeral shoulder injection
Methylprednisolone (MPA): injection into subacromial or glenohumeral space with MPA
|
Triamcinolone Acetonide (TA)
subacromial or glenohumeral shoulder injection
Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA
|
|---|---|---|
|
Overall Study
STARTED
|
205 209
|
216 227
|
|
Overall Study
COMPLETED
|
205 209
|
216 227
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain Increases After Shoulder Injection
Baseline characteristics by cohort
| Measure |
Methylprednisolone Acetate (MPA)
n=209 Person-visits
subacromial or glenohumeral shoulder injection
Methylprednisolone (MPA): injection into subacromial or glenohumeral space with MPA
|
Triamcinolone Acetonide (TA)
n=227 Person-visits
subacromial or glenohumeral shoulder injection
Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA
|
Total
n=436 Person-visits
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.19 years
STANDARD_DEVIATION 13.54 • n=99 Participants
|
60.64 years
STANDARD_DEVIATION 12.48 • n=107 Participants
|
62.37 years
STANDARD_DEVIATION 13.18 • n=206 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
222 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White American
|
149 Participants
n=99 Participants
|
161 Participants
n=107 Participants
|
310 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
52 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Others
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Injury/Pain Type
Acute
|
105 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
195 Participants
n=206 Participants
|
|
Injury/Pain Type
Chronic
|
100 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
226 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Post-injection day 1 through 7Population: The "Overall Number of Participants Analyzed" here reflects the number of person-visits for which data was able to be acquired. 16 person-visits in the MPA cohort were lost to follow-up during this time point, while 28 person-visits in the TA cohort were lost to follow-up during this time point. Loss to follow-up primarily was due to failure by subjects to mail their "home diary" VAS log.
A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain.
Outcome measures
| Measure |
Methylprednisolone Acetate (MPA)
n=209 Person-visits
subacromial or glenohumeral shoulder injection
Methylprednisolone (MPA): injection into subacromial or glenohumeral space with MPA
|
Triamcinolone Acetonide (TA)
n=227 Person-visits
subacromial or glenohumeral shoulder injection
Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA
|
|---|---|---|
|
Incidence of a Flare Reaction
Flare reaction (Yes)
|
44 Person-visits
|
8 Person-visits
|
|
Incidence of a Flare Reaction
Flare reaction (No)
|
149 Person-visits
|
191 Person-visits
|
|
Incidence of a Flare Reaction
Unknown
|
16 Person-visits
|
28 Person-visits
|
Adverse Events
Methylprednisolone Acetate (MPA)
Triamcinolone Acetonide (TA)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place