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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07692737
Enrollment
30
Registered
2026-07-09
Start date
2026-06-01
Completion date
2028-06-01
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lower Back Pain (CLBP), Lumbar Facet Joint Pain

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.

PROCEDUREMedial 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.

Sponsors

The New England Baptist Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Numeric Rating Scale on Pain Level4 months post-treatmentRange: 0-10 Higher score means more painful.

Secondary

MeasureTime frameDescription
Numeric Rating Scale on Pain Level1 month post-treatmentRange: 0-10 Higher score means more painful.
Oswestry Disability Index1 Month post-procedureRange: 0-100% Higher score means greater disability.
Patient Global Impression of Change1 month post-procedure7-point Likert scale 1 = very much improved, 7 = very much worse

Contacts

CONTACTRuijia Niu
research@nebh.org617-754-6732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026