Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain
Specific Aims The sacroiliac joint complex (SIJC) is a diathrodial, synovial joint and posterior ligamentous network that receives both anterior innervation from the lumbosacral plexus as well as posterior sensory innervation via the posterior sacral network (PSN). The PSN is comprised by the lateral branches S1-S3 pos
| Condition(s) | Sacroiliac Joint Complex, Low Back Pain |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Specific Aims The sacroiliac joint complex (SIJC) is a diathrodial, synovial joint and posterior ligamentous network that receives both anterior innervation from the lumbosacral plexus as well as posterior sensory innervation via the posterior sacral network (PSN). The PSN is comprised by the lateral branches S1-S3 posterior rami, with variable contributions from S4 lateral branch, L4 medial branch, and L5 dorsal ramus. Pain signals originating from the SIJC can be interrupted with image-guided percutaneous radiofrequency ablation (RFA) of the PSN, thereby reducing pain and disability in carefully selected patients. A prior systematic review estimated that 32-89% of patients achieve at least 50% pain relief for six months after some type of PSN ablation. Many experts suspect that heterogen |
| Who can participate | Inclusion Criteria: * Adult participants aged 18-90 years old with at least 3 months of low back pain who have not responded to at least 3 months of conservative treatment. * 7-day average NPRS for low back pain of at least 4/10 at baseline * Pain relieved by at least 50% by either a fluoroscopically-guided intraarticular sacroiliac joint injection including a local anesthetic and a fluoroscopically-guided PSN block or dual fluoroscopically-guided PSN blocks. * Participants capable of understanding and providing consent in English and capable of complying with the outcome instruments used. A pain diary with appropriate diagnostic categories of relief (100% relief, 80-99% relief, etc.), will be provided. Duration of pain relief will not be used as it has been shown to only marginally improv |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Lead sponsor | University of Utah |
| Locations | Farmington, Utah, United States; Salt Lake City, Utah, United States; South Jordan, Utah, United States |
| Start date | 2022-08-15 |
| NCT ID | NCT05409443 |
| Official listing | https://clinicaltrials.gov/study/NCT05409443 |