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This prospective study will be quantitatively analyzing the effectiveness of platelet-rich-plasma (PRP) injections into the sacroiliac (SI) joint in relieving sacroiliitis and low back pain originating from the SI joint. The effectiveness of PRP injections on joint pain has been well studied in the knee and shoulder. PRP injections are performed on the SI joint commonly, but there is little research documenting their effectiveness when compared to other interventions. This study will be a small pilot study to aid in closing this knowledge gap. Additionally, these injections will be performed under ultrasound guidance. Ultrasound has been proven to be of equal reliability to fluoroscopy and has the advantage of shorter time to administer and no radiation. There will be one arm to this study. The data collected will be compared to existing studies on corticosteroid SI joint injection. The experimental arm consists of the PRP injection. The PRP will be injected into the joint using the exact same technique via physical exam, special tests, and ultrasound guidance as performed in our previous studies. The outcomes will be measured with the Numeric Rating Scale for Pain (NRS) and the Oswestry Disability Index (ODI) prior to the injection, immediately post-injection, 2 weeks, 4 weeks, 3 months, and 6 months post-injection. The investigators hypothesis is, "Platelet-Rich Plasma Injections in the Sacroiliac Joint using ultrasonography in conjunction with physical examination and Point of Maximal Tenderness will produce statistically significant pain relief for more than 3 months as measured by the Numeric Rating Scale for Pain (NRS) and Oswestry Disability Index (ODI)."
PRP is not just an additional tool for physicians to use, but a potential treatment for underlying joint pathology. PRP is one of the closest treatments that exists for a definitive solution for inflammatory and degenerative joint disease. PRP is currently being used for dysfunction of the shoulder joint, knee joint, sacroiliac joint, facet joints, intervertebral discs, rotator cuff, hamstrings, and others. It has been extensively researched for osteoarthritis, tendon, and ligament injury of the knee, but little research has documented the short or long-term effects on the sacroiliac joint. A brief search on PubMed provides only two articles, one of which is a case study, and neither were performed in the United States. PRP is the future of orthopedics and physical medicine as well as a gateway to curing degenerative and inflammatory joint disease.
Furthermore, the use of ultrasound guided injections has helped increase the success rate because it provides a method for visualizing the path of the needle to a precise location. In recent studies, authors have indicated the use of a curvilinear transducer to be the most successful, as well as injections administered to the lower one third of the sacroiliac joint, to be adequately effective in diagnosing and treating sacroiliac joint pain. Disadvantages surrounding fluoroscopy include inconvenience, cost, radiation, and exposure to contrast media. Arranging the procedure can take extensive time and resources. The procedure can be costly for the patient, especially if it does not produce long-term results, and radiation exposure can have long-term consequences for the patient's health, rendering it a questionable treatment for chronic low back pain. As ultrasound guided and fluoroscopic sacroiliac joint injections present themselves as front-runners for diagnosis and treatment of sacroiliac joint-induced low back pain, the benefits and downsides to both are heavily weighed and compared. The next step moving forward in the treatment of the SI joint is administering PRP injections while utilizing ultrasonography for image guidance. The investigators believe this combination will provide the most immediate and long term benefit to patients as well as fewer risks from medications, corticosteroids, and fewer risks and downsides from fluoroscopy, such as radiation and cost.
Experimental design will be a nonrandomized trial (or quasi-experiment). The specific study design to be used is pretest-posttest design. The independent variable will be the PRP injection. The dependent variables of interest include the NRS and Oswestry Disability Index (ODI) recording pre-injection, immediately post-injection, 2 weeks, 4 weeks, 3 months, 6 months post-injection.
Most studies in the past look at short-term and moderate-term results up to approximately six months to one year. Many studies state a limitation to their data is the lack of long-term investigation into pain, disability, and function more than 12 months. This is partly due to losing patients to follow up. Patients whose pain resolved have no reason to return for further evaluation.
The investigators will take measures to avoid study bias and confounding by ensuring patients have been correctly diagnosed with sacroiliitis via special tests and physical examination as well as PMT. Additionally, to avoid confounding, the investigators will not administer PRP injections to patients who have had a corticosteroid injection in the SI joint within the last three months or received significant benefit from a corticosteroid injection. The efficacy of corticosteroids in the joint begin to dwindle starting at approximately three months.
This information will be recorded in each patient's chart as well as an Excel file only accessible to key personnel working on the study. The following data will be recorded form each patient: current pain scale using the NRS and their functionality using the ODI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma Joint Injection | Experimental | Venous blood will be drawn from the patient receiving injection treatment. It will be spun down to form PRP and reinjected back into the SI joint. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma Joint Injection | Drug | 30 to 50 milliliters of venous blood will be drawn from the patients arm with a 19 gauge ¾ inch needle using universal precautions. The venous blood will be mixed with 8 milliliters of anticoagulant citrate dextrose solution-A (ACD-A). The anti-coagulated blood will then be centrifuged for 15 minutes at 3200 revolutions per minute in the office centrifuge. This will allow plasma to separate from blood cells. The portion of centrifuged blood deficient in platelets will be extracted and discarded. Once the needle is visualized entering the joint capsule via ultrasound guidance and the physician feels resistance provided by the capsule and ligaments, 3 milliliters of PRP extract will be injected (3 inch, 22 gauge needle) into the sacroiliac joint. The needles will be properly disposed. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale for Pain (NRS) | Defined as a numeric scale for pain from 0 to 10. 0 demonstrates no pain and 10 demonstrates severe pain or significant impact on activities of daily living. | Change from baseline compared to 6 months post injection |
| Oswestry Disability Index (ODI) | Standardized questionnaire which asks 10 questions to assess impact on activities of daily living. Minimum score is 0, maximum score is 50. Higher scores mean worse outcome or more impact on function. | Change from baseline compared to 6 months post injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Hemler, MD | Star Spine and Sport, Rocky Vista University College of Osteopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Star Spine and Sport | Golden | Colorado | 80401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7709277 | Background | Schwarzer AC, Aprill CN, Bogduk N. The sacroiliac joint in chronic low back pain. Spine (Phila Pa 1976). 1995 Jan 1;20(1):31-7. doi: 10.1097/00007632-199501000-00007. | |
| 15473677 | Background | Dreyfuss P, Dreyer SJ, Cole A, Mayo K. Sacroiliac joint pain. J Am Acad Orthop Surg. 2004 Jul-Aug;12(4):255-65. doi: 10.5435/00124635-200407000-00006. |
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51 participants between the ages of 18 and 80 years old with chronic low back pain and a diagnosis of sacroiliitis were selected for this single center clinical trial. The Setting was a privately owned physical medicine and rehabilitation clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Platelet Rich Plasma Joint Injection | Venous blood will be drawn from the patient receiving injection treatment. It will be spun down to form PRP and reinjected back into the SI joint. Platelet Rich Plasma Joint Injection: 30 to 50 milliliters of venous blood will be drawn from the patients arm with a 19 gauge ¾ inch needle using universal precautions. The venous blood will be mixed with 8 milliliters of anticoagulant citrate dextrose solution-A (ACD-A). The anti-coagulated blood will then be centrifuged for 15 minutes at 3200 revolutions per minute in the office centrifuge. This will allow plasma to separate from blood cells. The portion of centrifuged blood deficient in platelets will be extracted and discarded. Once the needle is visualized entering the joint capsule via ultrasound guidance and the physician feels resistance provided by the capsule and ligaments, 3 milliliters of PRP extract will be injected (3 inch, 22 gauge needle) into the sacroiliac joint. The needles will be properly disposed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 25, 2023 |
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| 22994881 | Background | Vleeming A, Schuenke MD, Masi AT, Carreiro JE, Danneels L, Willard FH. The sacroiliac joint: an overview of its anatomy, function and potential clinical implications. J Anat. 2012 Dec;221(6):537-67. doi: 10.1111/j.1469-7580.2012.01564.x. Epub 2012 Sep 19. |
| Background | Lennard T, Fortin J. Sacroiliac Joint Injection and Arthrographic Imaging Correlation In: Physiatric Procedures in Clinical Practice. Philadelphia: Hanley & Belfus, 1995. 242-253. |
| 18690282 | Background | Harmon D, O'Sullivan M. Ultrasound-guided sacroiliac joint injection technique. Pain Physician. 2008 Jul-Aug;11(4):543-7. |
| 27677100 | Background | Singla V, Batra YK, Bharti N, Goni VG, Marwaha N. Steroid vs. Platelet-Rich Plasma in Ultrasound-Guided Sacroiliac Joint Injection for Chronic Low Back Pain. Pain Pract. 2017 Jul;17(6):782-791. doi: 10.1111/papr.12526. Epub 2016 Dec 1. |
| 27109909 | Background | Sakata R, Reddi AH. Platelet-Rich Plasma Modulates Actions on Articular Cartilage Lubrication and Regeneration. Tissue Eng Part B Rev. 2016 Oct;22(5):408-419. doi: 10.1089/ten.TEB.2015.0534. Epub 2016 Jun 27. |
| 27392848 | Background | Ko GD, Mindra S, Lawson GE, Whitmore S, Arseneau L. Case series of ultrasound-guided platelet-rich plasma injections for sacroiliac joint dysfunction. J Back Musculoskelet Rehabil. 2017;30(2):363-370. doi: 10.3233/BMR-160734. |
| 15085519 | Background | Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available. |
| 27386443 | Background | Zanon G, Combi F, Combi A, Perticarini L, Sammarchi L, Benazzo F. Platelet-rich plasma in the treatment of acute hamstring injuries in professional football players. Joints. 2016 Jun 13;4(1):17-23. doi: 10.11138/jts/2016.4.1.017. eCollection 2016 Jan-Mar. |
| 25670657 | Background | Andia I, Rubio-Azpeitia E, Maffulli N. Platelet-rich plasma modulates the secretion of inflammatory/angiogenic proteins by inflamed tenocytes. Clin Orthop Relat Res. 2015 May;473(5):1624-34. doi: 10.1007/s11999-015-4179-z. |
| 21844793 | Background | Chen CP, Lew HL, Tsai WC, Hung YT, Hsu CC. Ultrasound-guided injection techniques for the low back and hip joint. Am J Phys Med Rehabil. 2011 Oct;90(10):860-7. doi: 10.1097/PHM.0b013e318228c084. |
| 23221672 | Background | Chang WH, Lew HL, Chen CP. Ultrasound-guided sacroiliac joint injection technique. Am J Phys Med Rehabil. 2013 Mar;92(3):278-9. doi: 10.1097/PHM.0b013e318278d108. No abstract available. |
| Background | Hassan AS, El-Shafey AM, Ahmed HS, Hamed MS. Effectiveness of the intra-articular injection of platelet rich plasma in the treatment of patients with primary knee osteoarthritis. The Egyptian Rheumatologist. 2015;37(3):119-124. |
| 27891035 | Background | Kirchner F, Anitua E. Intradiscal and intra-articular facet infiltrations with plasma rich in growth factors reduce pain in patients with chronic low back pain. J Craniovertebr Junction Spine. 2016 Oct-Dec;7(4):250-256. doi: 10.4103/0974-8237.193260. |
| 25624776 | Background | Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015. |
| 23016084 | Background | Gobbi A, Karnatzikos G, Mahajan V, Malchira S. Platelet-rich plasma treatment in symptomatic patients with knee osteoarthritis: preliminary results in a group of active patients. Sports Health. 2012 Mar;4(2):162-72. doi: 10.1177/1941738111431801. |
| 19646379 | Background | Vianin M. Psychometric properties and clinical usefulness of the Oswestry Disability Index. J Chiropr Med. 2008 Dec;7(4):161-3. doi: 10.1016/j.jcm.2008.07.001. |
| 23380824 | Background | Joshi VD, Raiturker PP, Kulkarni AA. Validity and reliability of English and Marathi Oswestry Disability Index (version 2.1a) in Indian population. Spine (Phila Pa 1976). 2013 May 15;38(11):E662-8. doi: 10.1097/BRS.0b013e31828a34c3. |
| 26245709 | Background | Copay AG, Cher DJ. Is the Oswestry Disability Index a valid measure of response to sacroiliac joint treatment? Qual Life Res. 2016 Feb;25(2):283-292. doi: 10.1007/s11136-015-1095-3. Epub 2015 Aug 6. |
| 22588748 | Background | Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available. |
| 27302491 | Background | Barile A, La Marra A, Arrigoni F, Mariani S, Zugaro L, Splendiani A, Di Cesare E, Reginelli A, Zappia M, Brunese L, Duka E, Carrafiello G, Masciocchi C. Anaesthetics, steroids and platelet-rich plasma (PRP) in ultrasound-guided musculoskeletal procedures. Br J Radiol. 2016 Sep;89(1065):20150355. doi: 10.1259/bjr.20150355. Epub 2016 Jul 7. |
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not different from the assignment in participant flow
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet Rich Plasma Joint Injection | Venous blood will be drawn from the patient receiving injection treatment. It will be spun down to form PRP and reinjected back into the SI joint. Platelet Rich Plasma Joint Injection: 30 to 50 milliliters of venous blood will be drawn from the patients arm with a 19 gauge ¾ inch needle using universal precautions. The venous blood will be mixed with 8 milliliters of anticoagulant citrate dextrose solution-A (ACD-A). The anti-coagulated blood will then be centrifuged for 15 minutes at 3200 revolutions per minute in the office centrifuge. This will allow plasma to separate from blood cells. The portion of centrifuged blood deficient in platelets will be extracted and discarded. Once the needle is visualized entering the joint capsule via ultrasound guidance and the physician feels resistance provided by the capsule and ligaments, 3 milliliters of PRP extract will be injected (3 inch, 22 gauge needle) into the sacroiliac joint. The needles will be properly disposed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Baseline Pain - Numeric Rating Scale (NRS) | Numeric Rating Scale for pain measures pain levels on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain possible. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Baseline - Oswestry Disability Index (ODI) | Oswestry Disability Index measures amount of disability with a range from 0 to 50 with 0 being no disability and 50 being completely disabled. | Mean | Standard Deviation | units on a scale |
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| 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 | Numeric Rating Scale for Pain (NRS) | Defined as a numeric scale for pain from 0 to 10. 0 demonstrates no pain and 10 demonstrates severe pain or significant impact on activities of daily living. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline compared to 6 months post injection |
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| Primary | Oswestry Disability Index (ODI) | Standardized questionnaire which asks 10 questions to assess impact on activities of daily living. Minimum score is 0, maximum score is 50. Higher scores mean worse outcome or more impact on function. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline compared to 6 months post injection |
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6 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 | Platelet Rich Plasma Joint Injection | Venous blood will be drawn from the patient receiving injection treatment. It will be spun down to form PRP and reinjected back into the SI joint. Platelet Rich Plasma Joint Injection: 30 to 50 milliliters of venous blood will be drawn from the patients arm with a 19 gauge ¾ inch needle using universal precautions. The venous blood will be mixed with 8 milliliters of anticoagulant citrate dextrose solution-A (ACD-A). The anti-coagulated blood will then be centrifuged for 15 minutes at 3200 revolutions per minute in the office centrifuge. This will allow plasma to separate from blood cells. The portion of centrifuged blood deficient in platelets will be extracted and discarded. Once the needle is visualized entering the joint capsule via ultrasound guidance and the physician feels resistance provided by the capsule and ligaments, 3 milliliters of PRP extract will be injected (3 inch, 22 gauge needle) into the sacroiliac joint. The needles will be properly disposed. | 0 | 50 | 0 | 50 | 0 | 50 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Douglas Hemler, Prinical Investigator | Star Spine and Sports | 3035701834 | dhemler@starcolorado.com |
| Apr 26, 2023 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D058566 | Sacroiliitis |
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Baseline pain to 6-month post injection pain |
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