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| Name | Class |
|---|---|
| Radiological Society of North America | OTHER |
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The purpose of this study is to determine if platelet-rich plasma is superior to steroid/anesthetic for the treatment of sacroiliac joint pain.
All patients with sacroiliac joint pain diagnosed by a back pain specialist will undergo physical examination maneuvers and a test lidocaine injection of the joint. Patients who meet eligibility requirements will be randomized in a single-blind randomized controlled manner with a 50% chance of receiving platelet-rich plasma versus steroid/anesthetic injection of the sacroiliac joint(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich Plasma | Experimental | Patients will receive an intra-articular injection 3 mL of autologous platelet-rich plasma in the sacroiliac joint. |
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| Steroid/Anesthetic | Active Comparator | Patients will receive an intra-articular injection 40 mg Depo-medrol mixed with 2 mL 0.25% bupivicaine in the sacroiliac joint. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacroiliac intra-articular injection | Procedure | CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale | Validated pain scale rating pain on a scale of 0 through 10. 0 for no pain, and 10 for the highest pain the patient can imagine. | Change between baseline and 3-months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Oswestry Disability Questionnaire | Validated questionnaire used to evaluate function in patients with low back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. | Change between baseline and 3-months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Peckham, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States | ||
| Veterans Administration Salt Lake City Health Care System |
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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 | Mar 14, 2021 | Nov 3, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2021 | Apr 16, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Single-blind randomized controlled trial
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Patients will be blinded to which injectate they received.
| Short-Form 12 Survey | Validated survey used to evaluate function in patients with low back pain. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. | Change between baseline and 3-months post-intervention |
| Functional testing | 2 validated tests for low back pain "get up and go," "5 time sit to stand." Shorter times indicate better physical function, and longer times indicate poorer physical function. | Change between baseline and 3-months post-intervention |
| Opiate/pain medication usage questionnaire | Questionnaire on type, dose, and frequency of pain medications being used by the patient. All opiates will be converted to the morphine milligram equivalent scale with lower values indicating lower opiate content and higher values indicating higher opiate content | Change between baseline and 3-months post-intervention |
| Salt Lake City |
| Utah |
| 84148 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |