About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Platelet Rich Plasma Joint Injection
Procedure/SurgeryAutologous 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.
Medial branch radiofrequency ablation
Procedure/SurgeryLumbar 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.
Treatment groups
Trial outcomes
Primary outcomes
Numeric Rating Scale on Pain Level
Range: 0-10 Higher score means more painful.
Secondary outcomes
Numeric Rating Scale on Pain Level
Range: 0-10 Higher score means more painful.
Oswestry Disability Index
Range: 0-100% Higher score means greater disability.
Patient Global Impression of Change
7-point Likert scale 1 = very much improved, 7 = very much worse
Oswestry Disability Index
Range: 0-100% Higher score means greater disability.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: