NCT07692737

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

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Jun 2028

Study Start

First participant enrolled

June 1, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

June 18, 2026

Last Update Submit

July 7, 2026

Conditions

Chronic Lower Back Pain (CLBP)Lumbar Facet Joint Pain

Keywords

Platelet-Rich PlasmaPRPRadiofrequency AblationLumbar Facet JointMedial Branch NeurotomySpine Injection

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale on Pain Level

    Range: 0-10 Higher score means more painful.

    4 months post-treatment

Secondary Outcomes (11)

  • Numeric Rating Scale on Pain Level

    1 month post-treatment

  • Oswestry Disability Index

    1 Month post-procedure

  • Patient Global Impression of Change

    1 month post-procedure

  • Oswestry Disability Index

    4 months post-procedure

  • Patient Global Impression of Change

    4 months post-procedure

  • +6 more secondary outcomes

Study Arms (2)

Platelet-Rich-Plasma Injection

EXPERIMENTAL

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

Radiofrequency Ablation

ACTIVE COMPARATOR

Participants will undergo lumbar medial branch radiofrequency ablation (RFA) for the treatment of chronic lumbar facet-mediated pain.

Procedure: Medial branch radiofrequency ablation

Interventions

Platelet Rich Plasma Joint InjectionPROCEDURE

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.

Platelet-Rich-Plasma Injection
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.

Radiofrequency Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Ruijia Niu

CONTACT

617-754-6732research@nebh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Physiatry and Interventional Pain Physician

Study Record Dates

First Submitted

June 18, 2026

First Posted

July 9, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

July 9, 2026

Record last verified: 2026-07