Menu
Not yet recruiting NCT07692737

Lumbar Facet Platelet-Rich Plasma Injection Versus Medial Branch Radiofrequency Ablation for Chronic Lumbar Facet-Mediated Pain

No phase Interventional Chronic Lower Back Pain (CLBP) Lumbar Facet Joint Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Platelet Rich Plasma Joint Injection, Medial branch radiofrequency ablation.
Who it may be relevant to
Registry conditions: Chronic Lower Back Pain (CLBP), Lumbar Facet Joint Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial Comparing Intra-Periarticular Lumbar Facet Platelet-Rich Plasma Injection Versus Medial Branch Radiofrequency Ablation for Chronic Lumbar Facet-Mediated Pain

Overview

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

  • Procedure Platelet Rich Plasma Joint Injection
    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.
  • Procedure Medial branch radiofrequency ablation
    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.

Primary outcome measures

  • Numeric Rating Scale on Pain Level [Time frame: 4 months post-treatment]
Secondary outcome measures (11)
  • Numeric Rating Scale on Pain Level [Time frame: 1 month post-treatment]
  • Oswestry Disability Index [Time frame: 1 Month post-procedure]
  • Patient Global Impression of Change [Time frame: 1 month post-procedure]
  • Oswestry Disability Index [Time frame: 4 months post-procedure]
  • Patient Global Impression of Change [Time frame: 4 months post-procedure]
  • Numeric Rating Scale on Pain Level [Time frame: 6 months post-treatment]
  • Oswestry Disability Index [Time frame: 6 months post-procedure]
  • Patient Global Impression of Change [Time frame: 6 months post-procedure]
  • Numeric Rating Scale on Pain Level [Time frame: 12 months post-treatment]
  • Oswestry Disability Index [Time frame: 12 months post-procedure]
  • Patient Global Impression of Change [Time frame: 12 months post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07692737 · 2418263

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗