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NCT Number: NCT07692737

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

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Key information

Conditions

Chronic Lower Back Pain (CLBP) Lumbar Facet Joint Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet Rich Plasma Joint Injection

Procedure

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

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.

Primary outcomes

  1. Numeric Rating Scale on Pain Level

    Time frame: 4 months post-treatment

    Range: 0-10 Higher score means more painful.

Secondary outcomes

  1. Numeric Rating Scale on Pain Level

    Time frame: 1 month post-treatment

    Range: 0-10 Higher score means more painful.

  2. Oswestry Disability Index

    Time frame: 1 Month post-procedure

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

  3. Patient Global Impression of Change

    Time frame: 1 month post-procedure

    7-point Likert scale

    1 = very much improved, 7 = very much worse

  4. Oswestry Disability Index

    Time frame: 4 months post-procedure

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

  5. Patient Global Impression of Change

    Time frame: 4 months post-procedure

    7-point Likert scale

    1 = very much improved, 7 = very much worse

  6. Numeric Rating Scale on Pain Level

    Time frame: 6 months post-treatment

    Range: 0-10 Higher score means more painful.

  7. Oswestry Disability Index

    Time frame: 6 months post-procedure

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

  8. Patient Global Impression of Change

    Time frame: 6 months post-procedure

    7-point Likert scale

    1 = very much improved, 7 = very much worse

  9. Numeric Rating Scale on Pain Level

    Time frame: 12 months post-treatment

    Range: 0-10 Higher score means more painful.

  10. Oswestry Disability Index

    Time frame: 12 months post-procedure

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

  11. Patient Global Impression of Change

    Time frame: 12 months post-procedure

    7-point Likert scale

    1 = very much improved, 7 = very much worse

Study contacts

Contact information is provided by the study sponsor or research team.

Ruijia Niu

CONTACT

[email protected]

617-754-6732

Sponsors and collaborators

Lead sponsor

The New England Baptist Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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