Trial Outcomes & Findings for Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint (NCT NCT03122119)
NCT ID: NCT03122119
Last Updated: 2023-04-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
Change from baseline compared to 6 months post injection
Results posted on
2023-04-28
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Did not meet eligibility critria
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Platelet Rich Plasma Joint Injection
n=50 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=50 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 17 • n=50 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=50 Participants
|
|
Baseline Pain - Numeric Rating Scale (NRS)
|
6.05 units on a scale
STANDARD_DEVIATION 1.69 • n=50 Participants
|
|
Baseline - Oswestry Disability Index (ODI)
|
37.86 units on a scale
STANDARD_DEVIATION 14.65 • n=50 Participants
|
PRIMARY outcome
Timeframe: Change from baseline compared to 6 months post injectionDefined 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.
Outcome measures
| Measure |
Platelet Rich Plasma Joint Injection
n=50 Participants
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.
|
|---|---|
|
Numeric Rating Scale for Pain (NRS)
Baseline pain to 2-week post injection pain
|
1.08 units on a scale
Interval 0.45 to 1.72
|
|
Numeric Rating Scale for Pain (NRS)
Baseline pain to 4-week post injection pain
|
1.58 units on a scale
Interval 1.02 to 2.14
|
|
Numeric Rating Scale for Pain (NRS)
Baseline pain to 3-month post injection pain
|
1.69 units on a scale
Interval 1.02 to 2.37
|
|
Numeric Rating Scale for Pain (NRS)
Baseline pain to 6-month post injection pain
|
1.94 units on a scale
Interval 1.14 to 2.78
|
PRIMARY outcome
Timeframe: Change from baseline compared to 6 months post injectionStandardized 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.
Outcome measures
| Measure |
Platelet Rich Plasma Joint Injection
n=50 Participants
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.
|
|---|---|
|
Oswestry Disability Index (ODI)
Baseline disability to 2-week post-injection disability
|
4.72 units on a scale
Interval 2.27 to 7.17
|
|
Oswestry Disability Index (ODI)
Baseline disability to 4-week post-injection disability
|
7.14 units on a scale
Interval 4.49 to 9.78
|
|
Oswestry Disability Index (ODI)
Baseline disability to 3-month post-injection disability
|
8.78 units on a scale
Interval 4.62 to 12.93
|
|
Oswestry Disability Index (ODI)
Baseline disability to 6-month post-injection disability
|
9.79 units on a scale
Interval 6.06 to 13.52
|
Adverse Events
Platelet Rich Plasma Joint Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Douglas Hemler, Prinical Investigator
Star Spine and Sports
Phone: 3035701834
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place