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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe New England Baptist Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Platelet Rich Plasma Joint Injection

    Procedure/Surgery

    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 ablation

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Platelet-Rich-Plasma InjectionExperimental treatment 1 intervention
Group B: Radiofrequency AblationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numeric Rating Scale on Pain Level

Range: 0-10 Higher score means more painful.

Time frame
4 months post-treatment

Secondary outcomes

1

Numeric Rating Scale on Pain Level

Range: 0-10 Higher score means more painful.

Time frame
1 month post-treatment
2

Oswestry Disability Index

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

Time frame
1 Month post-procedure
3

Patient Global Impression of Change

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

Time frame
1 month post-procedure
4

Oswestry Disability Index

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

Time frame
4 months post-procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: