Chronic Lower Back Pain (CLBP)NCT07692737
Lumbar Facet Platelet-Rich Plasma Injection Versus Medial Branch Radiofrequency Ablation for Chronic Lumbar Facet-Mediated Pain
A study testing Platelet Rich Plasma Joint Injection and Medial branch radiofrequency ablation in people with Chronic Lower Back Pain (CLBP) and Lumbar Facet Joint Pain, run by The New England Baptist Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lower Back Pain (CLBP), Lumbar Facet Joint Pain
- What is being tested?
- Platelet Rich Plasma Joint Injection and Medial branch radiofrequency ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- Platelet Rich Plasma Joint Injection, Medial branch radiofrequency ablation
- Keywords
- Platelet-Rich Plasma, PRP, Radiofrequency Ablation, Lumbar Facet Joint, Medial Branch Neurotomy, Spine Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma Joint InjectionProcedure or 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 ablationProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Medial branch radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale on Pain Level
Range: 0-10 Higher score means more painful.
Measured: 4 months post-treatment
Secondary outcomes (11)
Numeric Rating Scale on Pain Level
Range: 0-10 Higher score means more painful.
Measured: 1 month post-treatment
Oswestry Disability Index
Range: 0-100% Higher score means greater disability.
Measured: 1 Month post-procedure
Patient Global Impression of Change
7-point Likert scale
1 = very much improved, 7 = very much worse
Measured: 1 month post-procedure
Oswestry Disability Index
Range: 0-100% Higher score means greater disability.
Measured: 4 months post-procedure
Patient Global Impression of Change
7-point Likert scale
1 = very much improved, 7 = very much worse
Measured: 4 months post-procedure
Numeric Rating Scale on Pain Level
Range: 0-10 Higher score means more painful.
Measured: 6 months post-treatment
Oswestry Disability Index
Range: 0-100% Higher score means greater disability.
Measured: 6 months post-procedure
Patient Global Impression of Change
7-point Likert scale
1 = very much improved, 7 = very much worse
Measured: 6 months post-procedure
Numeric Rating Scale on Pain Level
Range: 0-10 Higher score means more painful.
Measured: 12 months post-treatment
Oswestry Disability Index
Range: 0-100% Higher score means greater disability.
Measured: 12 months post-procedure
Patient Global Impression of Change
7-point Likert scale
1 = very much improved, 7 = very much worse
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New England Baptist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Lederman, The New England Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692737
- Sponsor's protocol ID
- 2418263
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07692737
- Acronym / sponsor ID
- 2418263
- Keywords
- Platelet-Rich Plasma, PRP, Radiofrequency Ablation, Lumbar Facet Joint, Medial Branch Neurotomy, Spine Injection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The New England Baptist HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich-Plasma Injection | Experimental | Procedure: Platelet Rich Plasma Joint InjectionParticipants will receive fluoroscopically guided intra-periarticular lumbar facet platelet-rich plasma (PRP) injection for the treatment of chronic lumbar facet-mediated pain. |
| Radiofrequency Ablation | Active comparator | Procedure: Medial branch radiofrequency ablationParticipants will undergo lumbar medial branch radiofrequency ablation (RFA) for the treatment of chronic lumbar facet-mediated pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich Plasma Joint InjectionAutologous 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. | Procedure or surgery | Platelet-Rich-Plasma Injection |
| Medial branch radiofrequency ablationLumbar 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. | Procedure or surgery | Radiofrequency Ablation |
Primary outcome
Numeric Rating Scale on Pain Level
Time frame: 4 months post-treatment
Range: 0-10 Higher score means more painful.
11 secondary outcomes
Numeric Rating Scale on Pain Level
Time frame: 1 month post-treatment
Oswestry Disability Index
Time frame: 1 Month post-procedure
Patient Global Impression of Change
Time frame: 1 month post-procedure
Oswestry Disability Index
Time frame: 4 months post-procedure
Patient Global Impression of Change
Time frame: 4 months post-procedure
Numeric Rating Scale on Pain Level
Time frame: 6 months post-treatment
Oswestry Disability Index
Time frame: 6 months post-procedure
Patient Global Impression of Change
Time frame: 6 months post-procedure
Numeric Rating Scale on Pain Level
Time frame: 12 months post-treatment
Oswestry Disability Index
Time frame: 12 months post-procedure
Patient Global Impression of Change
Time frame: 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma Joint Injection and Medial branch radiofrequency ablation in people with Chronic Lower Back Pain (CLBP) and Lumbar Facet Joint Pain, run by The New England Baptist Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruijia Niu (617-754-6732, research@nebh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale on Pain Level (time frame: 4 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.