Shoulder Pain
Conditions
Brief summary
Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.
Detailed description
Corticosteroid injections are used to reduce pain and inflammation for various shoulder pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being self-limited, causes significant pain and dysfunction. A flare reaction is defined for the purposes the study to be an increase of two or more points on a visual analog scale reported by the subject. Currently, there is a paucity of literature to drive the decision-making process between different corticosteroid medications. This study will compare the incidences of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA) and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or subacromial space. Physicians administering a steroid injection in the shoulder will utilize MPA until 200 subjects have agreed to participate in this treatment arm. Enrollment will then be offered to 200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their shoulder pain regardless of willingness to participate in the follow up reported pain scores. There are no costs to subjects for study participation.
Interventions
DRUGMethylprednisolone (MPA)
injection into subacromial or glenohumeral space with MPA
injection into subacromial or glenohumeral space with TA
Sponsors
Campbell Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Subacromial or glenohumeral shoulder pain to be treated with steroid injection * Fluent in written and oral English * Willing and able to provide written consent * Willing to complete follow up pain scores (visual analog score)
Exclusion criteria
* Unable to provide written consent * Chronic pain syndrome * Unwilling to complete follow up pain scores (visual analog score)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of a Flare Reaction | Post-injection day 1 through 7 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Methylprednisolone Acetate (MPA) subacromial or glenohumeral shoulder injection
Methylprednisolone (MPA): injection into subacromial or glenohumeral space with MPA | 205 |
| Methylprednisolone Acetate (MPA) subacromial or glenohumeral shoulder injection
Methylprednisolone (MPA): injection into subacromial or glenohumeral space with MPA | 209 |
| Triamcinolone Acetonide (TA) subacromial or glenohumeral shoulder injection
Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA | 216 |
| Triamcinolone Acetonide (TA) subacromial or glenohumeral shoulder injection
Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA | 227 |
| Total | 857 |
Baseline characteristics
| Characteristic | Methylprednisolone Acetate (MPA) | Total | Triamcinolone Acetonide (TA) |
|---|---|---|---|
| Age, Continuous | 64.19 years STANDARD_DEVIATION 13.54 | 62.37 years STANDARD_DEVIATION 13.18 | 60.64 years STANDARD_DEVIATION 12.48 |
| Injury/Pain Type Acute | 105 Participants | 195 Participants | 90 Participants |
| Injury/Pain Type Chronic | 100 Participants | 226 Participants | 126 Participants |
| Race/Ethnicity, Customized African American | 52 Participants | 102 Participants | 50 Participants |
| Race/Ethnicity, Customized Others | 4 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized White American | 149 Participants | 310 Participants | 161 Participants |
| Sex: Female, Male Female | 105 Participants | 222 Participants | 117 Participants |
| Sex: Female, Male Male | 100 Participants | 199 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence of a Flare Reaction
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.
Time frame: Post-injection day 1 through 7
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Methylprednisolone Acetate (MPA) | Incidence of a Flare Reaction | Flare reaction (Yes) | 44 Person-visits |
| Methylprednisolone Acetate (MPA) | Incidence of a Flare Reaction | Flare reaction (No) | 149 Person-visits |
| Methylprednisolone Acetate (MPA) | Incidence of a Flare Reaction | Unknown | 16 Person-visits |
| Triamcinolone Acetonide (TA) | Incidence of a Flare Reaction | Flare reaction (Yes) | 8 Person-visits |
| Triamcinolone Acetonide (TA) | Incidence of a Flare Reaction | Flare reaction (No) | 191 Person-visits |
| Triamcinolone Acetonide (TA) | Incidence of a Flare Reaction | Unknown | 28 Person-visits |