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Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylprednisolone acetate (MPA) | Experimental | subacromial or glenohumeral shoulder injection |
|
| triamcinolone acetonide (TA) | Active Comparator | subacromial or glenohumeral shoulder injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone (MPA) | Drug | injection into subacromial or glenohumeral space with MPA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-injection day 1 through 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyler Brolin, MD | Campbell Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campbell Clinic | Germantown | Tennessee | 38138 | United States |
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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."
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylprednisolone Acetate (MPA) | subacromial or glenohumeral shoulder injection Methylprednisolone (MPA): injection into subacromial or glenohumeral space with MPA |
| FG001 | Triamcinolone Acetonide (TA) | subacromial or glenohumeral shoulder injection Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
4 patients in the MPA group received bilateral injections, for a total of 209 shoulders receiving a MPA injection. 11 patients in the TA group received bilateral injections, for a total of 227 shoulders receiving a TA injection. The name used in the study for the total number of injections, including bilateral injections, was "person-visits."
| ID | Title | Description |
|---|---|---|
| BG000 | Methylprednisolone Acetate (MPA) | subacromial or glenohumeral shoulder injection Methylprednisolone (MPA): injection into subacromial or glenohumeral space with MPA |
| BG001 | Triamcinolone Acetonide (TA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | 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. | Posted | Count of Units | Person-visits | Post-injection day 1 through 7 | Person-visits | Person-visits |
|
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Deaths, serious adverse advents, and other (non-serious adverse events) were not assessed for the study.
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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 Acetate (MPA) | subacromial or glenohumeral shoulder injection Methylprednisolone (MPA): injection into subacromial or glenohumeral space with MPA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Manager | Campbell Foundation | 9017595413 | mknack@campbell-foundation.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2020 | Feb 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Triamcinolone Acetonide (TA) | Drug | injection into subacromial or glenohumeral space with TA |
|
|
subacromial or glenohumeral shoulder injection
Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA
| BG002 | Total | Total of all reporting groups |
| Person-visits |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Injury/Pain Type | Count of Participants | Participants | Participants |
|
| OG001 | Triamcinolone Acetonide (TA) | subacromial or glenohumeral shoulder injection Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Triamcinolone Acetonide (TA) | subacromial or glenohumeral shoulder injection Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D014221 | Triamcinolone |
| D013259 | Steroids, Fluorinated |