PNS vs RFA for Back Pain

Overseen By Daniel H Cortes, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Previous spinal surgery, Neuromuscular disease, Allergic to ultrasound gel, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two treatments for back pain originating from the facet joints in the spine. One treatment uses peripheral nerve stimulation to relieve pain by blocking pain signals to the brain without harming the spinal muscles. The other treatment, radiofrequency ablation, is a common method that can relieve pain but may affect muscle function. Individuals diagnosed with facet joint pain who have not found relief from physical therapy might be suitable candidates for this study. As an unphased trial, this study provides an opportunity to explore innovative treatments for back pain relief.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that peripheral nerve stimulation (PNS) holds promise for treating chronic pain, with about two-thirds of patients experiencing significant relief. Long-term results are also positive, as many patients report lasting benefits. However, some side effects, such as infections and skin problems, have been noted.

Conversely, radiofrequency ablation (RFA), the current standard for treating facet joint pain, is generally well-tolerated and has been widely used for many years. While effective in relieving pain, it can sometimes cause muscle problems because it targets nerves directly.

In summary, both treatments have proven effective and generally safe, though they come with different potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Peripheral Nerve Stimulation (PNS) is unique because it offers a new way to tackle chronic back pain by directly targeting the nerves that send pain signals to the brain. Unlike the standard of care, Radiofrequency Ablation (RFA), which focuses on the facet joints in the spine, PNS aims to disrupt pain right at the nerve level, potentially providing more effective and precise relief. Researchers are excited about PNS because it's minimally invasive and could offer a promising alternative for those who don't respond well to current treatments like RFA.

What evidence suggests that this trial's treatments could be effective for back pain?

Research has shown that peripheral nerve stimulation (PNS), one of the treatments in this trial, can significantly relieve chronic back pain. Studies indicate that about two-thirds of patients experience at least 50% ongoing pain relief after PNS treatment. Long-term results are also encouraging, with many patients reporting lasting pain reduction. In contrast, radiofrequency ablation (RFA), the other treatment option in this trial, is a well-known method for treating facet joint pain. It uses heat to stop nerves from sending pain signals. Although RFA is effective, it can sometimes harm spinal muscles. This study compares these two treatments to determine which one offers better pain relief and improves spine function. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel H. Cortes, Ph.D.

Principal Investigator

Penn State University

Are You a Good Fit for This Trial?

This trial is for adults with facet joint pain who haven't found relief through physical therapy. Candidates must have a confirmed diagnosis via two positive nerve blocks and be assessed by a professional. Non-English speakers are excluded due to language barriers in the study.

Inclusion Criteria

Physical therapy didn't relieve my joint pain, so I need surgery.

I speak English and can participate in interviews.

I have been diagnosed with facet joint pain confirmed by two positive nerve blocks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Peripheral Nerve Stimulation or Radiofrequency Ablation for facet joint pain

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of muscle activity, pain intensity, and disability

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Peripheral Nerve Stimulation
• Radiofrequency Ablation

Trial Overview The study compares two treatments: Sprint PNS system, which stimulates nerves without damaging spinal muscles, and Radiofrequency Ablation (RFA), which involves heating nerves but may cause muscle denervation. It will assess pain relief and spine biomechanics.

How Is the Trial Designed?

Group I: Peripheral Nerve Stimulation Experimental Treatment 1 Intervention

Peripheral nerve stimulation (PNS) is a procedure used to relieve chronic back pain by targeting the nerves responsible for transmitting pain signals from the back to the brain. It is a minimally invasive approach that aims to disrupt the pain signals and provide pain relief.

Group II: Radiofrequency Ablation Active Control 1 Intervention

Radiofrequency ablation (RFA) is the current standard of care for facet joint pain. It is a minimally invasive procedure used to relieve chronic back or neck pain caused by issues with the small joints in the spine called facet joints.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11801347/

Real-world long-term outcomes of peripheral nerve stimulation Patients report clinically meaningful long-term pain relief after receiving PNS through both 60-day and permanent implant systems.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8586061/

Peripheral Nerve Stimulation for Chronic Pain: A Systematic ... The evidence suggests that approximately two-thirds of patients with peripheral neuropathic pain will have at least 50% sustained pain relief.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772594423000699

Durable patient-reported outcomes following 60-day ... Treatment of CLBP with 60-day percutaneous PNS treatment produced clinically meaningful improvements in average pain intensity, disability, and/or pain ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07166952

Peripheral Nerve Stimulation With the SPRINT® System in ... Results of this trial have demonstrated PNS to be effective as both a short term and long-term treatment of PSIJC pain, finding average ODI ...

5. link.springer.com link.springer.com/article/10.1007/s40122-025-00737-3

Four-Year Follow-Up from a Prospective, Multicenter Study ... The present work explores the long-term clinical outcomes of Percutaneous 60-day PNS for chronic LBP approximately 4 years after initial treatment.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715925000315

An Analysis of the MAUDE Data base and Implications for ... Our analysis of the MAUDE data base revealed that infection, lead migration, and skin erosion were the most commonly reported AEs associated with the use of ...

7. mdpi.com mdpi.com/2077-0383/14/11/3964

Patient-Reported Outcomes with Peripheral Nerve ... This case series suggests that PNS may significantly reduce pain and pain interference while enhancing physical function in patients with vertebra plana ...