Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/29/2018 |
| Start Date: | April 1, 2017 |
| End Date: | March 2020 |
Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint to Relieve Low Back Pain
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, 6 months, 9 months, and 1
year 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)."
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, 6 months, 9 months, and 1
year 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, 9 months, and 1 year 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. The
data collected in regards to each patient's pain and function will be analyzed using summary
statistics to include mean, median, and mode, basic T-test, and P-value.
The proposed analytic approach utilizes basic statistical analysis to include a t-test in
order to calculate p-values. This study will require a p-value of less than .05 to be
considered statistically significant. Statistical procedures will also include summary
statistics such as mean, median, mode, standard error of mean, and standard deviation. Sample
size will be approximately 50 injections per arm. This is the amount the investigators
calculated that is required to demonstrate statistical significance. Variables that are
missing will not be used for data collection and will be thrown out.
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, 9 months, and 1 year 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. The
data collected in regards to each patient's pain and function will be analyzed using summary
statistics to include mean, median, and mode, basic T-test, and P-value.
The proposed analytic approach utilizes basic statistical analysis to include a t-test in
order to calculate p-values. This study will require a p-value of less than .05 to be
considered statistically significant. Statistical procedures will also include summary
statistics such as mean, median, mode, standard error of mean, and standard deviation. Sample
size will be approximately 50 injections per arm. This is the amount the investigators
calculated that is required to demonstrate statistical significance. Variables that are
missing will not be used for data collection and will be thrown out.
Inclusion Criteria:
- Diagnosis of sacroiliitis
- Age 18 to 80 years old
- Chronic low back pain
- SI joint pathology is the predominant source of pain
- Positive Fortin Finger Test (PMT)
- Joint anatomy is identifiable using ultrasonography
- Patient has no other comorbidities that contraindicate the procedure
- Patient has attempted physical therapy and corticosteroid injections with local
anesthetic -Previous injections of lidocaine and corticosteroid provided at least
minor immediate relief
- Patient must not have had a corticosteroid injection in the SI joint within the last
three months
- Patient must consent to the procedure
Exclusion Criteria:
- Patients under the age of 18 (Subjects under the age of 18 will not be included in
this study due to the continued growth and development of their joints and unstudied
effects on children.)
- Over the age of 80
- Multiple pain sources and multifactorial pain sources that complicated or confound
diagnosing the SI joint as the primary and predominant pain generator that may
contribute to low back pain (including but not limited to: lumbar diagnosis, lumbar
radiculopathy, intra or extra-articular hip pathology to include acetabulum and
femoral head, lumbo-sacral joint pathology, intervertebral disk disease,
spondylolisthesis/spondylosis/spondylolysis of lumbar vertebra)
- Immunosuppressed/immune compromised
- Underlying comorbidities that contraindicate the procedure (including but not limited
to polycythemia, coagulation disorder, or malignancy).
We found this trial at
1
site
2801 Youngfield Street
Golden, Colorado 80401
Golden, Colorado 80401
Principal Investigator: Douglas Hemler, MD
Phone: 303-238-4277
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