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

N/ANot Yet RecruitingNCT07692737

The New England Baptist Hospital30 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lower Back Pain (CLBP)Lumbar Facet Joint Pain

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.

Medial branch radiofrequency ablationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Numeric Rating Scale on Pain Level

Range: 0-10 Higher score means more painful.

Time frame: 4 months post-treatment

Secondary Outcomes

Numeric Rating Scale on Pain Level

Range: 0-10 Higher score means more painful.

Time frame: 1 month post-treatment

Oswestry Disability Index

Range: 0-100% Higher score means greater disability.

Time frame: 1 Month post-procedure

Patient Global Impression of Change

7-point Likert scale 1 = very much improved, 7 = very much worse

Time frame: 1 month post-procedure

Oswestry Disability Index

Range: 0-100% Higher score means greater disability.

Time frame: 4 months post-procedure

Patient Global Impression of Change

7-point Likert scale 1 = very much improved, 7 = very much worse

Time frame: 4 months post-procedure

Numeric Rating Scale on Pain Level

Range: 0-10 Higher score means more painful.

Time frame: 6 months post-treatment

Oswestry Disability Index

Range: 0-100% Higher score means greater disability.

Time frame: 6 months post-procedure

Patient Global Impression of Change

7-point Likert scale 1 = very much improved, 7 = very much worse

Time frame: 6 months post-procedure

Numeric Rating Scale on Pain Level

Range: 0-10 Higher score means more painful.

Time frame: 12 months post-treatment

Oswestry Disability Index

Range: 0-100% Higher score means greater disability.

Time frame: 12 months post-procedure

Patient Global Impression of Change

7-point Likert scale 1 = very much improved, 7 = very much worse

Time frame: 12 months post-procedure

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts