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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Facet Joint Pain; Chronic Lower Back Pain (CLBP)
• Intervention / Treatment: Procedure: Platelet Rich Plasma Joint Injection; Procedure: Medial branch radiofrequency ablation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruijia Niu; Phone Number: 617-754-6732; Email: research@nebh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-Rich-Plasma Injection; Participants will receive fluoroscopically guided intra-periarticular lumbar facet platelet-rich plasma (PRP) injection for the treatment of chronic lumbar facet-mediated pain.	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.
Active Comparator: Radiofrequency Ablation; Participants will undergo lumbar medial branch radiofrequency ablation (RFA) for the treatment of chronic lumbar facet-mediated pain.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale on Pain Level	Range: 0-10 Higher score means more painful.	4 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale on Pain Level	Range: 0-10 Higher score means more painful.	1 month post-treatment
Oswestry Disability Index	Range: 0-100% Higher score means greater disability.	1 Month post-procedure
Patient Global Impression of Change	7-point Likert scale 1 = very much improved, 7 = very much worse	1 month post-procedure
Oswestry Disability Index	Range: 0-100% Higher score means greater disability.	4 months post-procedure
Patient Global Impression of Change	7-point Likert scale 1 = very much improved, 7 = very much worse	4 months post-procedure
Numeric Rating Scale on Pain Level	Range: 0-10 Higher score means more painful.	6 months post-treatment
Oswestry Disability Index	Range: 0-100% Higher score means greater disability.	6 months post-procedure
Patient Global Impression of Change	7-point Likert scale 1 = very much improved, 7 = very much worse	6 months post-procedure
Numeric Rating Scale on Pain Level	Range: 0-10 Higher score means more painful.	12 months post-treatment
Oswestry Disability Index	Range: 0-100% Higher score means greater disability.	12 months post-procedure
Patient Global Impression of Change	7-point Likert scale 1 = very much improved, 7 = very much worse	12 months post-procedure

Collaborators and Investigators

• Sponsor: The New England Baptist Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; PRP; Platelet-Rich Plasma; Lumbar Facet Joint; Medial Branch Neurotomy; Spine Injection
• Other Study ID Numbers: 2418263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No