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recruitment and staffing
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Comparing two different corticosteroids (dexamethasone and triamcinolone) for use in sacroiliac joint injections
Patients eligible for a sacroiliac joint injection will be randomized to receive one of two different steroids, dexamethasone or triamcinolone. The response immediately after injection will be assessed to confirm the diagnosis, and then they will be followed for three month to assess the degree of pain relief experienced
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | dexamethasone injected into the sacroiliac joint |
|
| Triamcinolone | Active Comparator | triamcinolone injected into the sacroiliac joint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone injection into the sacroiliac joint |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Using Numeric Pain Rating Score | Numeric pain rating score, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection. Pain was assessed monthly from baseline to 3 months following the injection. The average value at month 3 is reported. | Baseline to 3 months; Average value at month 3 reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byron Schneider | Assistant professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byron Schneider | Nashville | Tennessee | 37067 | United States |
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18 of the 41 patients enrolled had a negative diagnostic response to initial injection and were not followed due to the negative screen after enrollment
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | dexamethasone injected into the sacroiliac joint Dexamethasone: Dexamethasone injection into the sacroiliac joint |
| FG001 | Triamcinolone | triamcinolone injected into the sacroiliac joint Triamcinolone Acetonide: Triamcinolone injection into the sacroiliac joint |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
the other 18 patients with a negative diagnostic response were not included in the study after the negative screen
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | dexamethasone injected into the sacroiliac joint Dexamethasone: Dexamethasone injection into the sacroiliac joint |
| BG001 | Triamcinolone | triamcinolone injected into the sacroiliac joint Triamcinolone Acetonide: Triamcinolone injection into the sacroiliac joint |
| 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 | Pain Using Numeric Pain Rating Score | Numeric pain rating score, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection. Pain was assessed monthly from baseline to 3 months following the injection. The average value at month 3 is reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3 months; Average value at month 3 reported |
|
baseline to 3 months
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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 | Dexamethasone | dexamethasone injected into the sacroiliac joint Dexamethasone: Dexamethasone injection into the sacroiliac joint |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Byron Schneider | Vanderbilt University Medical Center | (615)936-7708 | byron.j.schneider@vumc.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 | Jun 15, 2017 | Apr 19, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Triamcinolone Acetonide | Drug | Triamcinolone injection into the sacroiliac joint |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Triamcinolone | triamcinolone injected into the sacroiliac joint Triamcinolone Acetonide: Triamcinolone injection into the sacroiliac joint | 0 | 14 | 0 | 14 | 0 | 14 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D014221 | Triamcinolone |