Chronic Lower Back Pain (CLBP), Lumbar Facet Joint Pain
Conditions
Keywords
Platelet-Rich Plasma, PRP, Radiofrequency Ablation, Lumbar Facet Joint, Medial Branch Neurotomy, Spine Injection
Brief summary
The first clinical research effort under this initiative is a pilot randomized controlled trial comparing intra-periarticular lumbar facet platelet-rich plasma (PRP) injection to standard-of-care medial branch radiofrequency ablation (RFA) for chronic lumbar facet-mediated pain. The study is designed to: * Use contemporary best-practice techniques for both treatment arms * Minimize incremental risk beyond standard care * Generate feasibility, safety, and preliminary comparative effectiveness data * Inform future definitive trials and potential program expansion
Interventions
Autologous platelet-rich plasma (PRP) will be prepared using the Arthrex ACP double-syringe system according to manufacturer instructions. PRP will be injected into the lumbar facet joint and/or periarticular region under fluoroscopic guidance using sterile technique.
Lumbar medial branch radiofrequency ablation will be performed under fluoroscopic guidance using standard thermal radiofrequency lesioning techniques targeting the medial branch nerves supplying the symptomatic lumbar facet joints.
Sponsors
Study design
Eligibility
Inclusion criteria
* Adults with chronic lumbar back pain suspected to be facet-mediated * ≥80% pain relief following two diagnostic medial branch blocks * Ability to provide informed consent * Ability to complete patient-reported outcome measures
Exclusion criteria
* Active radiculopathy or alternate dominant spinal pain generator * Prior lumbar fusion at target level * Active systemic infection or local infection at injection site * Thrombocytopenia, less than 100,000/uL * Anemia, Hemoglobin less than 10 g/dL * Pregnancy * Inability to complete follow-up assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale on Pain Level | 4 months post-treatment | Range: 0-10 Higher score means more painful. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale on Pain Level | 1 month post-treatment | Range: 0-10 Higher score means more painful. |
| Oswestry Disability Index | 1 Month post-procedure | Range: 0-100% Higher score means greater disability. |
| Patient Global Impression of Change | 1 month post-procedure | 7-point Likert scale 1 = very much improved, 7 = very much worse |