Radiofrequency (RF) therapy is a minimally invasive technique that uses targeted electromagnetic energy to interrupt pain transmission along sensory nerve fibers. The Stratus system applies controlled RF energy to specific nerve pathways, producing either thermal lesions (continuous RF) or neuromodulatory effects (pulsed RF) without causing structural damage to surrounding tissues. This leads to reduced pain signaling and improved functional outcomes.
Unique Features of the Stratus Device
The Stratus device integrates multi-tined electrodes that create a bipolar strip lesion, ensuring >95% capture of the posterior sacral network (PSN) compared to <15% with conventional monopolar RF.
Key features include:
- Precision targeting under fluoroscopic guidance
- Larger and more homogeneous lesions for better efficacy
- Short procedural times with minimal radiation exposure
- Compatibility with multiple anatomical targets (SI joint, cervical medial branches, TON)
Main Indications: Chronic and Neuropathic Pain
Clinical evidence supports Stratus RF in treating:
- Sacroiliac joint pain (confirmed via diagnostic PSN blocks)
- Cervical pain involving the third occipital nerve (TON) or medial branches
- Chronic low back pain resistant to conservative therapies
- Neuropathic pain where peripheral nerve involvement is suspected
Pulsed vs. Continuous Radiofrequency: Key Differences
Stratus supports both RF modes:
- Continuous RF: generates controlled thermal lesions, leading to long-lasting denervation of pain pathways.
- Pulsed RF: delivers energy in short bursts, modulating pain transmission without creating thermal damage.
Clinical choice depends on patient selection, pain etiology, and desired duration of effect.
Patient Benefits and Expected Outcomes
Patients undergoing Stratus RF typically experience:
- >50% pain reduction in most cases (COBRA-SIJ trial)
- Improved functional scores (ODI, EQ-5D, PGIC)
- Reduced opioid and medication use
- Minimal downtime, with return to normal activities within days
- Sustained benefits lasting up to 24 months, with the option for repeat procedures if needed
Contraindications and When to Avoid Treatment
Stratus RF is not recommended in patients with:
- Active infections or recent antibiotic therapy
- Implanted neurostimulators or pacemakers without precautions
- Severe psychiatric conditions or uncontrolled depression
- Pregnancy, severe coagulopathies, or systemic inflammatory diseases
- Ongoing litigation or disability compensation linked to pain complaints
References
COBRA-SIJ Clinical Trial – “Comparison of Conventional and Bipolar Radiofrequency Ablation for Sacroiliac Joint Pain: COBRA-SIJ Study Protocol and Results” – Detailed methodology, patient inclusion criteria, and clinical outcomes (ODI, NPRS, EQ-5D).
Nimbus Stratus Device Technical Data – “Multi-Tined Electrode for Bipolar Lesioning: Mechanism of Action and Neural Capture Efficiency” – Device specifications and lesioning parameters.
Safety Data and IFU – “Stratus Medical Radiofrequency Ablation System: Instructions for Use and Safety Profile” – Risk management, contraindications, and adverse event incidence.
Clinical Evidence Review – “Long-Term Efficacy of Bipolar Sacroiliac RFA: Meta-Analysis and Observational Data” – Real-world data supporting sustained benefits up to 24 months.
Guidelines – “International Recommendations for Minimally Invasive Pain Interventions (SIJ and Cervical Neurotomy)” – Position statements from pain societies.
