Phase 4
N=51
Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint
Chronic Low Back Pain · Sacroiliitis · Sacroiliac; Backache · Platelet Rich Plasma · Platelet
Bottom Line
View on ClinicalTrials.gov: NCT03122119 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Numeric Rating Scale for Pain (NRS) — 1.08; 1.58; 1.69; 1.94 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Platelet Rich Plasma Joint Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Star Spine and Sport
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale for Pain (NRS) |
1.08; 1.58; 1.69; 1.94 | — |
| PRIMARY Oswestry Disability Index (ODI) |
4.72; 7.14; 8.78; 9.79 | — |
Summary
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)."
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03122119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.